HAWK: Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Study Details
Study Description
Brief Summary
The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Subjects were randomized to brolucizumab 3 mg, brolucizumab 6 mg,and aflibercept 2 mg in a 1:1:1 ratio. Subjects in all treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks.
Subjects in the brolucizumab 3 mg and brolucizumab 6 mg arms followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study.
Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study.
Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Brolucizumab 3 mg Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
Drug: Brolucizumab ophthalmic solution
Ophthalmic solution for IVT injection
Other Names:
|
Experimental: Brolucizumab 6 mg Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit |
Drug: Brolucizumab ophthalmic solution
Ophthalmic solution for IVT injection
Other Names:
|
Active Comparator: Aflibercept 2 mg Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Drug: Aflibercept ophthalmic solution
Ophthalmic solution for IVT injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye [Baseline, Week 48]
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Secondary Outcome Measures
- Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye [Baseline, Weeks 36, 40, 44, 48]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
- Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 [Weeks 16, 20, 28, 32, 40, 44, 48]
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for brolucizumab 3mg and 6 mg arms only.
- Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the First q12 Cycle (Week 16, Week 20) [Weeks 16, 20, 28, 32, 40, 44, 48]
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
- Proportion of Subjects With Positive q12 Treatment Status up to Week 96 [Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96]
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
- Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12 Cycle (Week 16, Week 20) [Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96]
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
- Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye [Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye [Baseline, Weeks 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye [Baseline, Weeks 36, 40, 44, 48]
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye [Baseline, Weeks 84, 88, 92, 96]
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
- Average Change From Baseline in CSFTtot Over the Period Week 4 Through Week 48/96 - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
- Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye [Baseline, Weeks 12, 48, 96]
CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
- Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye [Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
Central subfield neurosensory retinal thickness was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
Sub-RPE fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye [Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96]
Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits [Weeks 36, 40, 44, 48]
Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. For each subject, the number of visits with SRF and/or IRF fluid is analyzed.
- Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye [Week 16]
A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% CI for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
- Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 [Baseline, Weeks 24, 48, 72, 96]
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from age-related macular degeneration (AMD) subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.
- Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) [Week 48]
Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. Hypothesis testing not pre-specified.
- Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye [Baseline, Weeks 12, 48, 96]
Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
- Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye [Baseline, Weeks 12, 48, 96]
Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Provide written informed consent
-
Active choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) that affected the central subfield in the study eye at Screening;
-
Total area of CNV comprising >50% of the total lesion area in the study eye at Screening;
-
Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening;
-
Best Corrected Visual Acuity (BCVA) between 78 and 23 letters, inclusive, in the study eye at Screening and Baseline using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
Key Exclusion Criteria:
-
Any active intraocular or periocular infection or active intraocular inflammation in either eye at Baseline;
-
Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at Screening;
-
Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening;
-
Any approved or investigational treatment for neovascular age-related macular degeneration (nAMD) in the study eye at any time;
-
Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline;
-
Pregnant or nursing women; women of child-bearing potential;
-
Stroke or myocardial infarction in the 90-day period prior to Baseline.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Group Trial Lead, Novartis Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.- RTH258-C001
- CRTH258A2301
Study Results
Participant Flow
Recruitment Details | Subjects were recruited from investigative sites located in Argentina, Australia, Canada, Colombia, Israel, Japan, Mexico, New Zealand, Panama, Puerto Rico, and USA. |
---|---|
Pre-assignment Detail | Of the 1775 subjects enrolled in the study, 693 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Period Title: Overall Study | |||
STARTED | 360 | 361 | 361 |
Randomized and Treated | 358 | 360 | 360 |
COMPLETED | 310 | 304 | 297 |
NOT COMPLETED | 50 | 57 | 64 |
Baseline Characteristics
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
---|---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit | Total of all reporting groups |
Overall Participants | 358 | 360 | 360 | 1078 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
76.7
(8.28)
|
76.7
(8.95)
|
76.2
(8.80)
|
76.5
(8.68)
|
Age, Customized (Count of Participants) | ||||
Less than 50 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
50-64 years |
31
8.7%
|
35
9.7%
|
37
10.3%
|
103
9.6%
|
65-74 years |
103
28.8%
|
103
28.6%
|
112
31.1%
|
318
29.5%
|
75-84 years |
162
45.3%
|
155
43.1%
|
148
41.1%
|
465
43.1%
|
85 years and greater |
62
17.3%
|
67
18.6%
|
63
17.5%
|
192
17.8%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
210
58.7%
|
205
56.9%
|
194
53.9%
|
609
56.5%
|
Male |
148
41.3%
|
155
43.1%
|
166
46.1%
|
469
43.5%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
32
8.9%
|
29
8.1%
|
40
11.1%
|
101
9.4%
|
Not Hispanic or Latino |
323
90.2%
|
329
91.4%
|
319
88.6%
|
971
90.1%
|
Unknown or Not Reported |
3
0.8%
|
2
0.6%
|
1
0.3%
|
6
0.6%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
1
0.3%
|
1
0.3%
|
1
0.3%
|
3
0.3%
|
Asian |
44
12.3%
|
61
16.9%
|
53
14.7%
|
158
14.7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
1
0.3%
|
1
0.3%
|
1
0.3%
|
3
0.3%
|
White |
302
84.4%
|
285
79.2%
|
287
79.7%
|
874
81.1%
|
More than one race |
1
0.3%
|
3
0.8%
|
1
0.3%
|
5
0.5%
|
Unknown or Not Reported |
9
2.5%
|
9
2.5%
|
17
4.7%
|
35
3.2%
|
Best Corrected Visual Acuity (BCVA) (letters read) (letters) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [letters] |
61.0
(13.57)
|
60.8
(13.66)
|
60.0
(13.92)
|
60.6
(13.71)
|
Outcome Measures
Title | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Week 48 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF) |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Mean (Standard Deviation) [letters] |
5.9
(13.49)
|
6.4
(14.40)
|
7.0
(13.16)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | The non-inferiority margin was 4 letters. | |
Statistical Test of Hypothesis | p-Value | 0.0003 |
Comments | 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05. | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 1.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.98 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | The non-inferiority margin was 4 letters. | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05. | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 36, 40, 44, 48 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Mean (Standard Deviation) [letters] |
6.0
(13.37)
|
6.5
(13.85)
|
6.9
(12.61)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | The non-inferiority margin was 4 letters. | |
Statistical Test of Hypothesis | p-Value | 0.0001 |
Comments | 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05. | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 1.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.95 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | The non-inferiority margin was 4 letters. | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | 1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05. | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.96 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 |
---|---|
Description | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for brolucizumab 3mg and 6 mg arms only. |
Time Frame | Weeks 16, 20, 28, 32, 40, 44, 48 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - efficacy/safety approach |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg |
---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit |
Measure Participants | 358 | 360 |
Number (95% Confidence Interval) [proportion of subjects] |
0.4939
|
0.5563
|
Title | Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the First q12 Cycle (Week 16, Week 20) |
---|---|
Description | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only. |
Time Frame | Weeks 16, 20, 28, 32, 40, 44, 48 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - efficacy/safety approach |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg |
---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit |
Measure Participants | 208 | 222 |
Number (95% Confidence Interval) [proportion of subjects] |
0.8085
|
0.8539
|
Title | Proportion of Subjects With Positive q12 Treatment Status up to Week 96 |
---|---|
Description | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only. |
Time Frame | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - efficacy/safety approach |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg |
---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit |
Measure Participants | 358 | 360 |
Number (95% Confidence Interval) [proportion of subjects] |
0.3973
|
0.4537
|
Title | Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12 Cycle (Week 16, Week 20) |
---|---|
Description | Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only. |
Time Frame | Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - efficacy/safety approach |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg |
---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit |
Measure Participants | 208 | 222 |
Number (95% Confidence Interval) [proportion of subjects] |
0.6504
|
0.6963
|
Title | Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
3.7
(8.36)
|
3.8
(9.77)
|
4.2
(7.93)
|
Change from baseline at Week 8 |
5.7
(8.83)
|
5.5
(10.71)
|
6.1
(9.48)
|
Change from baseline at Week 12 |
5.7
(10.19)
|
6.0
(11.71)
|
6.3
(10.41)
|
Change from baseline at Week 16 |
5.7
(11.44)
|
6.3
(11.65)
|
6.1
(10.89)
|
Change from baseline at Week 20 |
6.2
(11.40)
|
6.2
(12.30)
|
7.1
(11.25)
|
Change from baseline at Week 24 |
6.1
(11.95)
|
6.4
(12.50)
|
6.8
(11.72)
|
Change from baseline at Week 28 |
6.2
(12.67)
|
6.7
(13.23)
|
6.7
(12.30)
|
Change from baseline at Week 32 |
5.6
(13.42)
|
6.8
(13.41)
|
6.6
(12.43)
|
Change from baseline at Week 36 |
5.6
(13.45)
|
6.5
(13.74)
|
7.1
(12.46)
|
Change from baseline at Week 40 |
6.2
(13.96)
|
6.6
(14.55)
|
6.9
(12.96)
|
Change from baseline at Week 44 |
6.2
(14.05)
|
6.6
(14.01)
|
6.7
(13.37)
|
Change from baseline at Week 48 |
5.9
(13.49)
|
6.4
(14.40)
|
7.0
(13.16)
|
Change from baseline at Week 52 |
6.2
(14.00)
|
6.2
(14.58)
|
6.8
(14.10)
|
Change from baseline at Week 56 |
6.2
(14.08)
|
6.1
(14.88)
|
7.1
(13.31)
|
Change from baseline at Week 60 |
6.2
(14.26)
|
6.2
(14.72)
|
6.7
(13.96)
|
Change from baseline at Week 64 |
5.9
(14.67)
|
6.0
(15.16)
|
6.6
(13.75)
|
Change from baseline at Week 68 |
6.0
(14.60)
|
5.9
(15.10)
|
6.5
(13.95)
|
Change from baseline at Week 72 |
6.0
(14.95)
|
5.6
(14.80)
|
6.2
(14.50)
|
Change from baseline at Week 76 |
6.2
(14.91)
|
5.9
(15.09)
|
6.3
(14.21)
|
Change from baseline at Week 80 |
6.1
(14.83)
|
6.1
(15.33)
|
5.8
(14.42)
|
Change from baseline at Week 84 |
5.8
(15.01)
|
5.5
(14.94)
|
5.6
(14.36)
|
Change from baseline at Week 88 |
5.8
(15.43)
|
5.7
(15.45)
|
5.8
(14.67)
|
Change from baseline at Week 92 |
5.8
(15.48)
|
5.8
(15.21)
|
5.9
(14.64)
|
Change from baseline at Week 96 |
5.4
(15.86)
|
5.6
(15.62)
|
5.6
(14.78)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 0.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.59 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 1.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.64 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.67 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.73 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.76 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.80 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 1.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.82 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -1.1 to 2.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.82 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.83 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.86 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.88 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.92 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 2.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.92 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 1.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.94 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -1.2 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.94 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 0.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.94 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.95 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.98 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 2.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 2.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 1.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.98 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 1.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -2.7 to 1.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.03 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 1.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.05 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 2.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.05 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -2.0 to 2.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.07 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 2.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.07 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 2.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 2.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.07 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 2.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 2.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 2.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.10 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 2.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.10 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.10 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.09 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.12 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 2.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.10 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline over the period Week 4 to 48 |
5.7
(10.43)
|
6.2
(11.62)
|
6.5
(10.49)
|
Change from baseline over the period Week 4 to 96 |
5.8
(12.06)
|
6.0
(12.73)
|
6.4
(11.76)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.76 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.80 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 1.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.88 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline over the period Week 12 to 48 |
5.9
(11.45)
|
6.5
(12.28)
|
6.7
(11.27)
|
Change from baseline over the period Week 12 to 96 |
5.9
(12.76)
|
6.1
(13.21)
|
6.5
(12.28)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -2.0 to 1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.83 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.85 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.91 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 1.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.92 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Mean (Standard Deviation) [letters] |
5.7
(15.15)
|
5.7
(15.05)
|
5.7
(14.29)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 2.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
9.2
|
10.8
|
9.7
|
Change from baseline at Week 8 |
15.9
|
19.2
|
15.6
|
Change from baseline at Week 12 |
20.1
|
24.4
|
20.3
|
Change from baseline at Week 16 |
22.6
|
22.5
|
20.8
|
Change from baseline at Week 20 |
22.6
|
25.8
|
22.8
|
Change from baseline at Week 24 |
23.2
|
28.3
|
21.9
|
Change from baseline at Week 28 |
27.4
|
28.1
|
25.8
|
Change from baseline at Week 32 |
25.4
|
31.9
|
25.0
|
Change from baseline at Week 36 |
24.9
|
31.7
|
24.7
|
Change from baseline at Week 40 |
27.1
|
33.6
|
26.4
|
Change from baseline at Week 44 |
27.7
|
34.2
|
27.5
|
Change from baseline at Week 48 |
24.9
|
33.1
|
25.8
|
Change from baseline at Week 52 |
29.9
|
31.7
|
28.1
|
Change from baseline at Week 56 |
29.9
|
31.7
|
29.7
|
Change from baseline at Week 60 |
27.7
|
32.5
|
28.6
|
Change from baseline at Week 64 |
30.7
|
32.5
|
27.8
|
Change from baseline at Week 68 |
29.9
|
32.5
|
28.1
|
Change from baseline at Week 72 |
30.4
|
31.4
|
27.5
|
Change from baseline at Week 76 |
33.8
|
32.5
|
28.6
|
Change from baseline at Week 80 |
28.5
|
35.6
|
27.8
|
Change from baseline at Week 84 |
29.3
|
30.0
|
26.7
|
Change from baseline at Week 88 |
31.0
|
34.7
|
27.8
|
Change from baseline at Week 92 |
28.8
|
32.8
|
28.1
|
Change from baseline at Week 96 |
32.1
|
33.6
|
27.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 5.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -4.4 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.2 | |
Confidence Interval |
(2-Sided) 95% -1.2 to 10.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.9 | |
Confidence Interval |
(2-Sided) 95% -0.5 to 11.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 8.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -3.8 to 8.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 9.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 7.2 | |
Confidence Interval |
(2-Sided) 95% 0.8 to 13.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 8.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.2 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 9.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 7.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 7.9 | |
Confidence Interval |
(2-Sided) 95% 1.5 to 14.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 7.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 8.1 | |
Confidence Interval |
(2-Sided) 95% 2.1 to 14.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -4.4 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 8.3 | |
Confidence Interval |
(2-Sided) 95% 2.0 to 15.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 7.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 7.6 | |
Confidence Interval |
(2-Sided) 95% 0.7 to 13.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -6.8 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 8.2 | |
Confidence Interval |
(2-Sided) 95% 2.2 to 15.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 9.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.8 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 11.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 7.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.0 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 9.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -6.5 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.9 | |
Confidence Interval |
(2-Sided) 95% -1.3 to 11.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.7 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 10.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.8 | |
Confidence Interval |
(2-Sided) 95% -0.4 to 12.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 9.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.6 | |
Confidence Interval |
(2-Sided) 95% -0.2 to 11.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 9.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.1 | |
Confidence Interval |
(2-Sided) 95% -1.1 to 11.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 6.0 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 12.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.0 | |
Confidence Interval |
(2-Sided) 95% -1.0 to 11.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 8.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 8.8 | |
Confidence Interval |
(2-Sided) 95% 2.7 to 15.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.3 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 9.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.2 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 10.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.1 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 10.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 8.0 | |
Confidence Interval |
(2-Sided) 95% 1.9 to 14.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 8.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.9 | |
Confidence Interval |
(2-Sided) 95% -0.0 to 12.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.5 | |
Confidence Interval |
(2-Sided) 95% -1.2 to 12.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 7.2 | |
Confidence Interval |
(2-Sided) 95% 1.4 to 13.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
19.3
|
24.4
|
19.2
|
Change from baseline at Week 8 |
30.7
|
32.5
|
32.2
|
Change from baseline at Week 12 |
33.2
|
38.6
|
33.9
|
Change from baseline at Week 16 |
35.2
|
39.7
|
35.6
|
Change from baseline at Week 20 |
37.2
|
42.2
|
38.3
|
Change from baseline at Week 24 |
40.2
|
41.9
|
39.4
|
Change from baseline at Week 28 |
41.1
|
43.9
|
41.4
|
Change from baseline at Week 32 |
38.3
|
43.9
|
41.7
|
Change from baseline at Week 36 |
41.1
|
43.3
|
43.1
|
Change from baseline at Week 40 |
41.3
|
45.3
|
44.2
|
Change from baseline at Week 44 |
44.4
|
43.1
|
44.2
|
Change from baseline at Week 48 |
41.3
|
45.3
|
44.2
|
Change from baseline at Week 52 |
43.0
|
43.9
|
44.2
|
Change from baseline at Week 56 |
44.4
|
42.5
|
45.3
|
Change from baseline at Week 60 |
41.6
|
45.6
|
43.6
|
Change from baseline at Week 64 |
43.0
|
44.7
|
40.6
|
Change from baseline at Week 68 |
44.7
|
44.2
|
43.6
|
Change from baseline at Week 72 |
45.3
|
41.9
|
41.9
|
Change from baseline at Week 76 |
45.0
|
44.4
|
44.4
|
Change from baseline at Week 80 |
41.3
|
43.6
|
43.3
|
Change from baseline at Week 84 |
43.3
|
42.8
|
42.2
|
Change from baseline at Week 88 |
44.4
|
43.6
|
41.7
|
Change from baseline at Week 92 |
44.1
|
43.3
|
40.8
|
Change from baseline at Week 96 |
43.6
|
43.9
|
39.7
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 6.3 | |
Confidence Interval |
(2-Sided) 95% 0.6 to 12.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 8.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 7.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 6.0 | |
Confidence Interval |
(2-Sided) 95% -0.8 to 12.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -6.0 to 7.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.6 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 12.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -6.5 to 7.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.2 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 12.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.5 | |
Confidence Interval |
(2-Sided) 95% -4.0 to 9.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 11.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 8.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.9 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 11.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -8.2 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.6 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 10.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -7.3 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 8.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -7.8 to 6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 10.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -4.4 to 9.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -7.1 to 7.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -7.9 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -4.5 to 9.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -6.8 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 8.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.3 | |
Confidence Interval |
(2-Sided) 95% -8.6 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -7.0 to 7.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.4 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 11.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.0 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 10.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.5 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 13.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.7 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 9.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 9.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.2 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 12.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 8.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.5 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 9.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 8.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -6.9 to 7.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 8.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.0 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 10.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 9.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.6 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 11.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.3 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 10.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.1 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 12.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.9 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 11.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.6 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 12.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.7 | |
Confidence Interval |
(2-Sided) 95% -1.0 to 12.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
40.2
|
43.3
|
43.1
|
Change from baseline at Week 8 |
54.2
|
53.1
|
56.1
|
Change from baseline at Week 12 |
54.7
|
58.6
|
57.8
|
Change from baseline at Week 16 |
54.7
|
59.2
|
58.6
|
Change from baseline at Week 20 |
57.5
|
56.9
|
62.2
|
Change from baseline at Week 24 |
59.2
|
63.1
|
61.7
|
Change from baseline at Week 28 |
60.1
|
61.7
|
61.7
|
Change from baseline at Week 32 |
60.1
|
61.7
|
59.7
|
Change from baseline at Week 36 |
58.1
|
59.2
|
65.8
|
Change from baseline at Week 40 |
60.1
|
63.1
|
63.1
|
Change from baseline at Week 44 |
60.9
|
62.5
|
65.6
|
Change from baseline at Week 48 |
59.2
|
61.1
|
65.6
|
Change from baseline at Week 52 |
61.5
|
60.6
|
64.2
|
Change from baseline at Week 56 |
62.3
|
60.8
|
62.2
|
Change from baseline at Week 60 |
61.7
|
60.6
|
61.9
|
Change from baseline at Week 64 |
59.5
|
61.4
|
61.9
|
Change from baseline at Week 68 |
61.2
|
60.3
|
64.7
|
Change from baseline at Week 72 |
59.8
|
60.6
|
60.0
|
Change from baseline at Week 76 |
60.3
|
60.3
|
59.7
|
Change from baseline at Week 80 |
60.1
|
58.1
|
58.3
|
Change from baseline at Week 84 |
58.9
|
58.6
|
58.6
|
Change from baseline at Week 88 |
58.9
|
57.8
|
61.7
|
Change from baseline at Week 92 |
59.2
|
58.3
|
61.4
|
Change from baseline at Week 96 |
61.7
|
58.1
|
58.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -7.7 to 6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -5.3 to 8.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -7.4 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.8 | |
Confidence Interval |
(2-Sided) 95% -8.9 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.4 | |
Confidence Interval |
(2-Sided) 95% -8.1 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 8.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -5.3 to 8.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.1 | |
Confidence Interval |
(2-Sided) 95% -9.7 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.1 | |
Confidence Interval |
(2-Sided) 95% -11.4 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -7.6 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.5 | |
Confidence Interval |
(2-Sided) 95% -4.4 to 10.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -7.2 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -6.3 to 7.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 9.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.1 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 10.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.0 | |
Confidence Interval |
(2-Sided) 95% -12.6 to 1.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.4 | |
Confidence Interval |
(2-Sided) 95% -12.7 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -8.1 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -9.6 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.0 | |
Confidence Interval |
(2-Sided) 95% -9.1 to 5.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.6 | |
Confidence Interval |
(2-Sided) 95% -11.1 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.5 | |
Confidence Interval |
(2-Sided) 95% -10.4 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -8.0 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.7 | |
Confidence Interval |
(2-Sided) 95% -9.7 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -7.2 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -7.2 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -7.9 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -9.4 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.1 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 8.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 9.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 9.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 8.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.2 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 10.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 8.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.2 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 5.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.5 | |
Confidence Interval |
(2-Sided) 95% -9.7 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -7.9 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -9.1 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.6 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 11.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 8.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
1.7
|
3.1
|
1.4
|
Change from baseline at Week 8 |
1.7
|
2.8
|
2.2
|
Change from baseline at Week 12 |
3.4
|
3.6
|
3.9
|
Change from baseline at Week 16 |
3.1
|
3.6
|
3.3
|
Change from baseline at Week 20 |
2.5
|
4.7
|
2.5
|
Change from baseline at Week 24 |
4.2
|
5.3
|
3.9
|
Change from baseline at Week 28 |
4.7
|
5.6
|
4.4
|
Change from baseline at Week 32 |
5.3
|
6.4
|
4.2
|
Change from baseline at Week 36 |
4.7
|
6.4
|
3.3
|
Change from baseline at Week 40 |
5.0
|
6.9
|
4.2
|
Change from baseline at Week 44 |
5.6
|
6.4
|
4.4
|
Change from baseline at Week 48 |
5.9
|
6.4
|
5.6
|
Change from baseline at Week 52 |
6.1
|
6.9
|
5.8
|
Change from baseline at Week 56 |
6.4
|
7.8
|
5.3
|
Change from baseline at Week 60 |
5.9
|
6.9
|
5.8
|
Change from baseline at Week 64 |
7.3
|
8.6
|
5.8
|
Change from baseline at Week 68 |
7.3
|
7.5
|
6.4
|
Change from baseline at Week 72 |
7.3
|
7.5
|
6.1
|
Change from baseline at Week 76 |
6.7
|
8.1
|
6.1
|
Change from baseline at Week 80 |
7.3
|
7.8
|
8.1
|
Change from baseline at Week 84 |
8.7
|
7.8
|
7.2
|
Change from baseline at Week 88 |
8.7
|
8.1
|
8.1
|
Change from baseline at Week 92 |
8.7
|
8.1
|
6.9
|
Change from baseline at Week 96 |
8.7
|
8.1
|
7.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -0.5 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 1.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 2.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 2.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -0.3 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 3.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -2.0 to 4.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -1.0 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.1 | |
Confidence Interval |
(2-Sided) 95% 0.0 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -0.7 to 6.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -2.7 to 4.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.6 | |
Confidence Interval |
(2-Sided) 95% -1.5 to 6.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 4.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -1.3 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 4.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -2.7 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 5.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 4.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -3.6 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
3.6
|
4.4
|
4.2
|
Change from baseline at Week 8 |
3.4
|
3.9
|
3.9
|
Change from baseline at Week 12 |
4.7
|
5.8
|
5.8
|
Change from baseline at Week 16 |
5.0
|
4.2
|
5.6
|
Change from baseline at Week 20 |
4.5
|
6.4
|
5.3
|
Change from baseline at Week 24 |
5.9
|
8.6
|
6.4
|
Change from baseline at Week 28 |
7.8
|
7.8
|
7.2
|
Change from baseline at Week 32 |
7.8
|
7.8
|
7.2
|
Change from baseline at Week 36 |
8.4
|
8.9
|
6.9
|
Change from baseline at Week 40 |
8.1
|
9.2
|
8.3
|
Change from baseline at Week 44 |
8.7
|
8.6
|
8.1
|
Change from baseline at Week 48 |
9.5
|
8.9
|
7.5
|
Change from baseline at Week 52 |
8.9
|
11.1
|
8.3
|
Change from baseline at Week 56 |
9.8
|
10.3
|
7.8
|
Change from baseline at Week 60 |
8.9
|
10.6
|
9.4
|
Change from baseline at Week 64 |
10.6
|
11.1
|
9.2
|
Change from baseline at Week 68 |
10.3
|
11.4
|
9.2
|
Change from baseline at Week 72 |
10.3
|
11.1
|
12.2
|
Change from baseline at Week 76 |
8.9
|
12.2
|
10.0
|
Change from baseline at Week 80 |
9.8
|
12.5
|
10.8
|
Change from baseline at Week 84 |
11.5
|
12.8
|
10.8
|
Change from baseline at Week 88 |
11.7
|
12.2
|
12.2
|
Change from baseline at Week 92 |
11.5
|
11.7
|
11.9
|
Change from baseline at Week 96 |
12.0
|
14.7
|
12.5
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 2.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.2 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 2.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.5 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 2.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.6 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -2.6 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -3.6 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -3.7 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.0 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.5 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 3.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -3.8 to 5.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.9 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 3.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.1 | |
Confidence Interval |
(2-Sided) 95% -5.6 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.2 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 5.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 4.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -5.3 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -5.7 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
9.8
|
10.3
|
7.8
|
Change from baseline at Week 8 |
7.5
|
10.3
|
7.5
|
Change from baseline at Week 12 |
10.3
|
11.9
|
8.3
|
Change from baseline at Week 16 |
10.3
|
9.4
|
10.8
|
Change from baseline at Week 20 |
8.7
|
11.9
|
10.0
|
Change from baseline at Week 24 |
10.3
|
15.0
|
11.1
|
Change from baseline at Week 28 |
10.6
|
13.6
|
12.8
|
Change from baseline at Week 32 |
12.8
|
12.2
|
13.3
|
Change from baseline at Week 36 |
14.0
|
13.1
|
10.8
|
Change from baseline at Week 40 |
12.0
|
13.6
|
13.1
|
Change from baseline at Week 44 |
13.7
|
12.8
|
14.4
|
Change from baseline at Week 48 |
13.7
|
12.5
|
11.7
|
Change from baseline at Week 52 |
14.0
|
15.0
|
13.6
|
Change from baseline at Week 56 |
13.4
|
13.9
|
12.5
|
Change from baseline at Week 60 |
13.7
|
15.0
|
13.3
|
Change from baseline at Week 64 |
15.4
|
16.1
|
13.3
|
Change from baseline at Week 68 |
14.2
|
15.3
|
14.7
|
Change from baseline at Week 72 |
15.9
|
15.0
|
14.7
|
Change from baseline at Week 76 |
15.9
|
16.1
|
15.0
|
Change from baseline at Week 80 |
16.2
|
16.7
|
15.6
|
Change from baseline at Week 84 |
17.9
|
19.2
|
15.8
|
Change from baseline at Week 88 |
17.0
|
17.5
|
16.1
|
Change from baseline at Week 92 |
17.3
|
17.5
|
16.1
|
Change from baseline at Week 96 |
20.4
|
18.9
|
17.2
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 3.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.7 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.4 | |
Confidence Interval |
(2-Sided) 95% -0.9 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 3.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.3 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -1.4 to 8.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.3 | |
Confidence Interval |
(2-Sided) 95% -6.8 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 5.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -5.0 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.1 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 7.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -2.7 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.1 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 4.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -5.7 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -6.5 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -2.7 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 5.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -4.0 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -3.8 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -4.5 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -3.8 to 6.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.9 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 5.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 6.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 7.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.3 | |
Confidence Interval |
(2-Sided) 95% -2.9 to 8.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -4.5 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -4.5 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.4 | |
Confidence Interval |
(2-Sided) 95% -4.5 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -3.1 to 8.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 7.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye |
---|---|
Description | BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS-LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Baseline |
24.9
|
21.7
|
19.2
|
Week 4 |
34.6
|
33.3
|
33.9
|
Week 8 |
42.5
|
42.8
|
42.8
|
Week 12 |
45.3
|
43.9
|
45.8
|
Week 16 |
46.4
|
46.7
|
44.4
|
Week 20 |
46.4
|
46.9
|
48.1
|
Week 24 |
49.7
|
47.8
|
46.4
|
Week 28 |
48.9
|
49.7
|
46.9
|
Week 32 |
48.0
|
51.4
|
44.4
|
Week 36 |
47.8
|
50.6
|
48.3
|
Week 40 |
51.7
|
49.2
|
48.6
|
Week 44 |
49.7
|
50.0
|
50.3
|
Week 48 |
49.7
|
50.6
|
50.8
|
Week 52 |
48.6
|
50.6
|
49.2
|
Week 56 |
50.8
|
50.0
|
48.6
|
Week 60 |
52.0
|
48.1
|
49.2
|
Week 64 |
50.8
|
50.6
|
49.2
|
Week 68 |
50.6
|
48.3
|
46.7
|
Week 72 |
50.8
|
49.2
|
49.4
|
Week 76 |
52.2
|
49.2
|
46.1
|
Week 80 |
51.4
|
49.7
|
45.6
|
Week 84 |
50.6
|
47.2
|
45.3
|
Week 88 |
50.6
|
50.3
|
48.6
|
Week 92 |
51.7
|
49.4
|
45.8
|
Week 96 |
48.9
|
49.4
|
45.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -7.7 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.7 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 2.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -8.9 to 2.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -7.7 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.1 | |
Confidence Interval |
(2-Sided) 95% -8.9 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.0 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 2.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -6.3 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.0 | |
Confidence Interval |
(2-Sided) 95% -10.4 to 2.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.4 | |
Confidence Interval |
(2-Sided) 95% -9.4 to 2.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -4.6 to 6.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -6.5 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -4.9 to 7.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 7.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.1 | |
Confidence Interval |
(2-Sided) 95% -1.0 to 11.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -6.0 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.2 | |
Confidence Interval |
(2-Sided) 95% -7.4 to 5.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -8.8 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.2 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 4.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.5 | |
Confidence Interval |
(2-Sided) 95% -9.5 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -8.6 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -8.8 to 3.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -6.8 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -5.7 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -9.0 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -7.2 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 5.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 8.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -6.3 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -7.2 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 4.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.0 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 10.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 7.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.9 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 9.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 9.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.3 | |
Confidence Interval |
(2-Sided) 95% -3.0 to 9.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -6.0 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 9.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 8.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 7.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -3.8 to 9.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye |
---|---|
Description | CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
-142.2
(130.54)
|
-150.9
(120.85)
|
-137.8
(120.62)
|
Change from baseline at Week 8 |
-163.7
(139.68)
|
-169.1
(132.62)
|
-154.3
(126.05)
|
Change from baseline at Week 12 |
-172.5
(142.82)
|
-177.6
(137.13)
|
-157.3
(125.86)
|
Change from baseline at Week 16 |
-151.4
(145.66)
|
-159.6
(133.91)
|
-135.3
(132.50)
|
Change from baseline at Week 20 |
-151.5
(142.70)
|
-153.8
(144.23)
|
-161.1
(128.75)
|
Change from baseline at Week 24 |
-160.4
(151.33)
|
-164.6
(141.67)
|
-138.9
(136.02)
|
Change from baseline at Week 28 |
-169.1
(147.81)
|
-169.7
(146.82)
|
-161.8
(133.79)
|
Change from baseline at Week 32 |
-153.9
(154.59)
|
-157.0
(144.46)
|
-137.5
(142.15)
|
Change from baseline at Week 36 |
-173.0
(150.80)
|
-175.3
(147.18)
|
-160.2
(137.94)
|
Change from baseline at Week 40 |
-164.3
(153.85)
|
-166.9
(141.94)
|
-141.1
(144.80)
|
Change from baseline at Week 44 |
-165.1
(151.34)
|
-167.4
(156.10)
|
-160.3
(139.14)
|
Change from baseline at Week 48 |
-165.3
(152.86)
|
-170.9
(142.48)
|
-145.6
(145.53)
|
Change from baseline at Week 52 |
-174.4
(149.06)
|
-173.8
(149.18)
|
-162.9
(141.57)
|
Change from baseline at Week 56 |
-161.7
(148.33)
|
-161.6
(149.26)
|
-145.5
(145.95)
|
Change from baseline at Week 60 |
-177.4
(150.58)
|
-171.3
(152.35)
|
-162.8
(143.92)
|
Change from baseline at Week 64 |
-170.8
(160.61)
|
-166.2
(148.96)
|
-147.6
(145.88)
|
Change from baseline at Week 68 |
-171.7
(149.54)
|
-169.8
(151.91)
|
-160.6
(150.34)
|
Change from baseline at Week 72 |
-173.0
(152.01)
|
-169.5
(149.17)
|
-146.8
(151.89)
|
Change from baseline at Week 76 |
-176.6
(154.87)
|
-172.9
(153.90)
|
-161.4
(147.50)
|
Change from baseline at Week 80 |
-168.4
(157.11)
|
-167.1
(152.62)
|
-147.2
(156.73)
|
Change from baseline at Week 84 |
-181.7
(152.44)
|
-173.9
(157.54)
|
-166.4
(151.94)
|
Change from baseline at Week 88 |
-174.3
(154.83)
|
-171.1
(152.31)
|
-150.9
(157.20)
|
Change from baseline at Week 92 |
-176.9
(154.63)
|
-174.1
(157.30)
|
-165.8
(150.35)
|
Change from baseline at Week 96 |
-177.8
(155.03)
|
-172.9
(156.38)
|
-150.7
(154.86)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -7.9 | |
Confidence Interval |
(2-Sided) 95% -24.2 to 8.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.30 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -16.5 | |
Confidence Interval |
(2-Sided) 95% -31.9 to -1.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.86 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -13.7 | |
Confidence Interval |
(2-Sided) 95% -30.4 to 3.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.51 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.0 | |
Confidence Interval |
(2-Sided) 95% -35.0 to -2.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.16 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.7 | |
Confidence Interval |
(2-Sided) 95% -36.3 to -3.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.45 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -24.5 | |
Confidence Interval |
(2-Sided) 95% -40.7 to -8.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.24 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0159 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.9 | |
Confidence Interval |
(2-Sided) 95% -38.0 to -1.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.24 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0008 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -27.8 | |
Confidence Interval |
(2-Sided) 95% -45.1 to -10.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.80 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 5.2 | |
Confidence Interval |
(2-Sided) 95% -11.8 to 22.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.69 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 3.2 | |
Confidence Interval |
(2-Sided) 95% -14.1 to 20.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.80 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -25.8 | |
Confidence Interval |
(2-Sided) 95% -44.3 to -7.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.44 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -29.6 | |
Confidence Interval |
(2-Sided) 95% -47.5 to -11.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.13 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -11.6 | |
Confidence Interval |
(2-Sided) 95% -29.2 to 5.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.96 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -12.1 | |
Confidence Interval |
(2-Sided) 95% -29.8 to 5.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.98 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -20.1 | |
Confidence Interval |
(2-Sided) 95% -39.6 to -0.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.91 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -23.2 | |
Confidence Interval |
(2-Sided) 95% -42.1 to -4.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.64 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -17.4 | |
Confidence Interval |
(2-Sided) 95% -35.5 to 0.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.24 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.6 | |
Confidence Interval |
(2-Sided) 95% -37.6 to -1.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.14 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -27.3 | |
Confidence Interval |
(2-Sided) 95% -46.6 to -8.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.83 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -29.5 | |
Confidence Interval |
(2-Sided) 95% -48.2 to -10.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.50 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -9.3 | |
Confidence Interval |
(2-Sided) 95% -27.5 to 8.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.27 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -11.4 | |
Confidence Interval |
(2-Sided) 95% -30.3 to 7.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.64 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0075 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -23.9 | |
Confidence Interval |
(2-Sided) 95% -43.1 to -4.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.79 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0012 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -29.0 | |
Confidence Interval |
(2-Sided) 95% -47.6 to -10.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.47 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -15.6 | |
Confidence Interval |
(2-Sided) 95% -33.6 to 2.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.17 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -15.1 | |
Confidence Interval |
(2-Sided) 95% -33.4 to 3.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.35 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -20.0 | |
Confidence Interval |
(2-Sided) 95% -38.9 to -1.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.62 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -20.0 | |
Confidence Interval |
(2-Sided) 95% -39.4 to -0.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.86 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -18.8 | |
Confidence Interval |
(2-Sided) 95% -37.0 to -0.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.30 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -12.7 | |
Confidence Interval |
(2-Sided) 95% -31.4 to 6.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.56 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -27.2 | |
Confidence Interval |
(2-Sided) 95% -46.7 to -7.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.96 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -22.5 | |
Confidence Interval |
(2-Sided) 95% -41.6 to -3.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.73 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -14.9 | |
Confidence Interval |
(2-Sided) 95% -33.8 to 3.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.60 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -13.2 | |
Confidence Interval |
(2-Sided) 95% -32.6 to 6.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.88 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -29.9 | |
Confidence Interval |
(2-Sided) 95% -49.3 to -10.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.89 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -26.4 | |
Confidence Interval |
(2-Sided) 95% -46.0 to -6.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.99 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.3 | |
Confidence Interval |
(2-Sided) 95% -38.2 to -0.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.62 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -15.7 | |
Confidence Interval |
(2-Sided) 95% -35.0 to 3.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.84 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -24.8 | |
Confidence Interval |
(2-Sided) 95% -45.0 to -4.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.34 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -23.7 | |
Confidence Interval |
(2-Sided) 95% -43.9 to -3.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.32 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.5 | |
Confidence Interval |
(2-Sided) 95% -38.4 to -0.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.65 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -11.8 | |
Confidence Interval |
(2-Sided) 95% -31.5 to 8.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.05 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -27.3 | |
Confidence Interval |
(2-Sided) 95% -47.3 to -7.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.16 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -24.2 | |
Confidence Interval |
(2-Sided) 95% -44.3 to -4.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.22 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -15.1 | |
Confidence Interval |
(2-Sided) 95% -34.2 to 3.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.70 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -12.5 | |
Confidence Interval |
(2-Sided) 95% -32.1 to 7.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.99 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -30.9 | |
Confidence Interval |
(2-Sided) 95% -50.6 to -11.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -26.0 | |
Confidence Interval |
(2-Sided) 95% -46.2 to -5.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.28 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye |
---|---|
Description | CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 36, 40, 44, 48 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Mean (Standard Deviation) [micrometers] |
-166.9
(148.90)
|
-170.1
(143.48)
|
-151.8
(139.53)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0183 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.5 | |
Confidence Interval |
(2-Sided) 95% -37.7 to -1.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.29 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0075 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | ANOVA | |
Comments | Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors. | |
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -22.4 | |
Confidence Interval |
(2-Sided) 95% -40.4 to -4.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.19 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye |
---|---|
Description | CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Mean (Standard Deviation) [micrometers] |
-177.7
(153.15)
|
-173.0
(154.47)
|
-158.4
(151.86)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -23.2 | |
Confidence Interval |
(2-Sided) 95% -42.4 to -4.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.76 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -18.6 | |
Confidence Interval |
(2-Sided) 95% -38.3 to 1.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Average Change From Baseline in CSFTtot Over the Period Week 4 Through Week 48/96 - Study Eye |
---|---|
Description | CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline over the period Week 4 to 48 |
-161.0
(138.65)
|
-165.2
(135.36)
|
-149.3
(128.16)
|
Change from baseline over the period Week 4 to 96 |
-167.5
(143.12)
|
-167.8
(141.23)
|
-152.4
(135.75)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -16.0 | |
Confidence Interval |
(2-Sided) 95% -32.6 to 0.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.50 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.9 | |
Confidence Interval |
(2-Sided) 95% -36.5 to -3.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.45 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -18.9 | |
Confidence Interval |
(2-Sided) 95% -36.4 to -1.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 to Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -19.3 | |
Confidence Interval |
(2-Sided) 95% -36.9 to -1.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.93 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye |
---|---|
Description | CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 12, 48, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 12 |
-3.3
(4.15)
|
-3.8
(3.89)
|
-3.2
(3.45)
|
Change from baseline at Week 48 |
-3.9
(4.59)
|
-4.0
(3.89)
|
-3.5
(4.03)
|
Change from baseline at Week 96 |
-3.9
(4.62)
|
-4.1
(4.07)
|
-3.5
(4.17)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -0.8 to 0.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.23 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -1.0 to -0.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -1.1 to -0.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.24 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -0.9 to 0.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.22 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -1.3 to -0.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -1.1 to -0.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.23 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye |
---|---|
Description | Central subfield neurosensory retinal thickness was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis. |
Time Frame | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 4 |
-56.3
(86.09)
|
-62.1
(88.73)
|
-61.0
(85.59)
|
Change from baseline at Week 8 |
-63.7
(87.09)
|
-66.3
(93.11)
|
-63.2
(88.65)
|
Change from baseline at Week 12 |
-67.0
(88.75)
|
-68.3
(94.14)
|
-63.7
(88.73)
|
Change from baseline at Week 16 |
-57.2
(91.00)
|
-61.1
(92.12)
|
-54.9
(91.55)
|
Change from baseline at Week 20 |
-58.6
(90.20)
|
-59.4
(91.78)
|
-65.5
(89.46)
|
Change from baseline at Week 24 |
-63.4
(91.06)
|
-65.0
(97.16)
|
-57.3
(91.89)
|
Change from baseline at Week 28 |
-67.9
(92.89)
|
-66.1
(98.08)
|
-67.2
(89.40)
|
Change from baseline at Week 32 |
-58.6
(93.16)
|
-60.4
(97.42)
|
-59.0
(90.77)
|
Change from baseline at Week 36 |
-67.4
(94.43)
|
-69.2
(100.29)
|
-67.1
(92.55)
|
Change from baseline at Week 40 |
-64.0
(93.94)
|
-67.0
(98.18)
|
-61.8
(90.60)
|
Change from baseline at Week 44 |
-65.2
(91.89)
|
-67.4
(99.33)
|
-67.5
(92.08)
|
Change from baseline at Week 48 |
-66.3
(95.57)
|
-66.4
(98.85)
|
-64.3
(92.86)
|
Change from baseline at Week 52 |
-70.4
(95.07)
|
-69.8
(100.94)
|
-69.5
(94.15)
|
Change from baseline at Week 56 |
-66.9
(95.57)
|
-65.0
(100.26)
|
-65.2
(93.33)
|
Change from baseline at Week 60 |
-73.0
(97.26)
|
-69.0
(102.69)
|
-69.9
(95.32)
|
Change from baseline at Week 64 |
-69.5
(97.07)
|
-68.3
(101.20)
|
-66.5
(94.25)
|
Change from baseline at Week 68 |
-69.5
(97.06)
|
-68.4
(101.24)
|
-69.0
(94.73)
|
Change from baseline at Week 72 |
-70.8
(96.61)
|
-68.4
(99.73)
|
-65.1
(94.75)
|
Change from baseline at Week 76 |
-70.0
(101.51)
|
-70.8
(102.45)
|
-69.1
(95.26)
|
Change from baseline at Week 80 |
-67.2
(102.52)
|
-68.2
(100.77)
|
-67.1
(92.06)
|
Change from baseline at Week 84 |
-72.7
(101.96)
|
-71.3
(102.48)
|
-69.6
(93.53)
|
Change from baseline at Week 88 |
-71.5
(98.52)
|
-69.3
(100.95)
|
-66.9
(93.64)
|
Change from baseline at Week 92 |
-71.6
(99.16)
|
-71.2
(104.98)
|
-70.3
(93.71)
|
Change from baseline at Week 96 |
-71.8
(99.15)
|
-70.4
(101.71)
|
-64.9
(94.21)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 7.1 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 17.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.31 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -10.2 to 10.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.37 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 12.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.35 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -12.5 to 9.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.52 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -11.2 to 10.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.38 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -13.9 to 7.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.55 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -11.1 to 11.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.73 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -4.8 | |
Confidence Interval |
(2-Sided) 95% -16.1 to 6.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.76 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 9.3 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 20.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.56 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 7.6 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 18.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.58 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -3.6 | |
Confidence Interval |
(2-Sided) 95% -14.7 to 7.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.68 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -6.3 | |
Confidence Interval |
(2-Sided) 95% -17.9 to 5.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.92 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -8.8 to 12.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.51 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.6 | |
Confidence Interval |
(2-Sided) 95% -8.7 to 13.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.73 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.9 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 14.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.73 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -11.7 to 11.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.92 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -8.8 to 13.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.70 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -12.2 to 10.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.89 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -10.7 to 11.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.71 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -3.6 | |
Confidence Interval |
(2-Sided) 95% -15.0 to 7.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.83 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 4.9 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 15.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.62 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.5 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 13.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.8 | |
Confidence Interval |
(2-Sided) 95% -10.5 to 12.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.76 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -12.2 to 11.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.93 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -9.5 to 13.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.77 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% -10.6 to 13.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -10.6 to 12.4 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.6 | |
Confidence Interval |
(2-Sided) 95% -10.4 to 13.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -11.9 to 11.2 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.89 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.4 | |
Confidence Interval |
(2-Sided) 95% -9.7 to 14.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.17 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -11.7 to 11.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -12.2 to 11.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.09 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -9.3 to 13.9 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.91 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 14.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.08 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -2.9 | |
Confidence Interval |
(2-Sided) 95% -14.5 to 8.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.91 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -1.8 | |
Confidence Interval |
(2-Sided) 95% -13.7 to 10.1 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.06 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 13.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.05 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -12.2 to 11.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.13 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 2.8 | |
Confidence Interval |
(2-Sided) 95% -9.1 to 14.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.05 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.5 | |
Confidence Interval |
(2-Sided) 95% -11.3 to 12.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.01 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -11.9 to 11.5 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.95 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -12.0 to 11.7 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.04 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -1.7 | |
Confidence Interval |
(2-Sided) 95% -13.2 to 9.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.86 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -12.6 to 11.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.00 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 13.3 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.87 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -11.1 to 12.8 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.09 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -4.0 | |
Confidence Interval |
(2-Sided) 95% -15.6 to 7.6 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.91 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -3.9 | |
Confidence Interval |
(2-Sided) 95% -15.8 to 8.0 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.07 |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye |
---|---|
Description | Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 4 |
33.2
|
28.9
|
42.8
|
Week 8 |
19.0
|
12.8
|
27.5
|
Week 12 |
14.8
|
9.2
|
23.1
|
Week 16 |
26.0
|
16.9
|
36.7
|
Week 20 |
26.3
|
24.4
|
22.2
|
Week 24 |
23.5
|
13.1
|
36.4
|
Week 28 |
18.4
|
16.4
|
21.4
|
Week 32 |
28.2
|
23.9
|
36.1
|
Week 36 |
14.2
|
11.9
|
22.2
|
Week 40 |
21.5
|
16.1
|
27.5
|
Week 44 |
20.1
|
16.4
|
19.4
|
Week 48 |
18.2
|
14.4
|
30.0
|
Week 52 |
15.9
|
10.0
|
18.6
|
Week 56 |
20.4
|
18.1
|
27.5
|
Week 60 |
14.2
|
10.3
|
18.9
|
Week 64 |
18.7
|
14.4
|
26.4
|
Week 68 |
18.4
|
14.4
|
15.8
|
Week 72 |
16.2
|
11.4
|
23.9
|
Week 76 |
15.9
|
11.7
|
17.5
|
Week 80 |
17.6
|
12.2
|
23.9
|
Week 84 |
12.0
|
12.2
|
17.2
|
Week 88 |
17.3
|
11.7
|
23.3
|
Week 92 |
15.9
|
10.0
|
15.0
|
Week 96 |
15.6
|
10.3
|
21.4
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -9.4 | |
Confidence Interval |
(2-Sided) 95% -16.4 to -3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -14.2 | |
Confidence Interval |
(2-Sided) 95% -21.3 to -7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.4 | |
Confidence Interval |
(2-Sided) 95% -14.6 to -2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -15.0 | |
Confidence Interval |
(2-Sided) 95% -20.9 to -9.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.1 | |
Confidence Interval |
(2-Sided) 95% -13.8 to -2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -14.0 | |
Confidence Interval |
(2-Sided) 95% -18.9 to -8.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.4 | |
Confidence Interval |
(2-Sided) 95% -16.8 to -3.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -19.7 | |
Confidence Interval |
(2-Sided) 95% -25.8 to -13.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.1 | |
Confidence Interval |
(2-Sided) 95% -2.0 to 9.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 7.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.7 | |
Confidence Interval |
(2-Sided) 95% -19.1 to -6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -23.4 | |
Confidence Interval |
(2-Sided) 95% -29.7 to -17.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.8 | |
Confidence Interval |
(2-Sided) 95% -8.7 to 3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.1 | |
Confidence Interval |
(2-Sided) 95% -11.2 to 0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.7 | |
Confidence Interval |
(2-Sided) 95% -14.3 to -1.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.4 | |
Confidence Interval |
(2-Sided) 95% -19.3 to -6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.8 | |
Confidence Interval |
(2-Sided) 95% -13.2 to -2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.3 | |
Confidence Interval |
(2-Sided) 95% -15.9 to -4.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.6 | |
Confidence Interval |
(2-Sided) 95% -11.5 to 0.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -11.4 | |
Confidence Interval |
(2-Sided) 95% -17.7 to -5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 6.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.1 | |
Confidence Interval |
(2-Sided) 95% -8.7 to 2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -11.6 | |
Confidence Interval |
(2-Sided) 95% -17.8 to -5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -15.6 | |
Confidence Interval |
(2-Sided) 95% -21.2 to -9.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.6 | |
Confidence Interval |
(2-Sided) 95% -8.0 to 3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.6 | |
Confidence Interval |
(2-Sided) 95% -13.7 to -3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.9 | |
Confidence Interval |
(2-Sided) 95% -12.6 to -0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -9.6 | |
Confidence Interval |
(2-Sided) 95% -16.0 to -3.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.5 | |
Confidence Interval |
(2-Sided) 95% -9.9 to 0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.5 | |
Confidence Interval |
(2-Sided) 95% -13.9 to -3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.4 | |
Confidence Interval |
(2-Sided) 95% -13.1 to -1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.0 | |
Confidence Interval |
(2-Sided) 95% -17.8 to -6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.7 | |
Confidence Interval |
(2-Sided) 95% -2.5 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.4 | |
Confidence Interval |
(2-Sided) 95% -6.7 to 3.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.5 | |
Confidence Interval |
(2-Sided) 95% -12.8 to -1.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.5 | |
Confidence Interval |
(2-Sided) 95% -18.2 to -7.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.4 | |
Confidence Interval |
(2-Sided) 95% -7.0 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.9 | |
Confidence Interval |
(2-Sided) 95% -11.4 to -0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.1 | |
Confidence Interval |
(2-Sided) 95% -11.8 to -0.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -11.7 | |
Confidence Interval |
(2-Sided) 95% -17.0 to -6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.1 | |
Confidence Interval |
(2-Sided) 95% -10.1 to 0.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.1 | |
Confidence Interval |
(2-Sided) 95% -10.0 to -0.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.7 | |
Confidence Interval |
(2-Sided) 95% -11.7 to 0.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -11.7 | |
Confidence Interval |
(2-Sided) 95% -17.3 to -6.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -4.0 to 6.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.0 | |
Confidence Interval |
(2-Sided) 95% -9.7 to -0.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.5 | |
Confidence Interval |
(2-Sided) 95% -11.4 to -0.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -11.1 | |
Confidence Interval |
(2-Sided) 95% -16.4 to -6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye |
---|---|
Description | Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 4 |
20.4
|
23.9
|
22.2
|
Week 8 |
17.9
|
20.8
|
22.5
|
Week 12 |
14.2
|
17.2
|
16.9
|
Week 16 |
22.3
|
20.3
|
24.7
|
Week 20 |
25.7
|
25.0
|
15.0
|
Week 24 |
22.9
|
17.8
|
26.9
|
Week 28 |
21.8
|
18.1
|
18.9
|
Week 32 |
24.6
|
21.9
|
24.4
|
Week 36 |
17.9
|
16.4
|
18.6
|
Week 40 |
20.7
|
19.7
|
24.2
|
Week 44 |
21.5
|
18.6
|
16.7
|
Week 48 |
21.8
|
21.4
|
22.2
|
Week 52 |
18.4
|
16.9
|
15.0
|
Week 56 |
23.7
|
20.8
|
21.1
|
Week 60 |
15.1
|
15.8
|
16.4
|
Week 64 |
20.4
|
17.8
|
20.8
|
Week 68 |
19.8
|
16.4
|
14.2
|
Week 72 |
17.6
|
15.0
|
18.3
|
Week 76 |
17.3
|
15.6
|
14.2
|
Week 80 |
19.3
|
18.6
|
18.3
|
Week 84 |
16.8
|
14.2
|
14.4
|
Week 88 |
20.7
|
16.7
|
16.7
|
Week 92 |
17.6
|
14.4
|
13.6
|
Week 96 |
19.3
|
15.0
|
20.0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.0 | |
Confidence Interval |
(2-Sided) 95% -7.9 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -4.1 to 7.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.5 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 1.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.5 | |
Confidence Interval |
(2-Sided) 95% -7.7 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.7 | |
Confidence Interval |
(2-Sided) 95% -7.6 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 5.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.5 | |
Confidence Interval |
(2-Sided) 95% -8.3 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.3 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 10.6 | |
Confidence Interval |
(2-Sided) 95% 5.0 to 16.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 10.0 | |
Confidence Interval |
(2-Sided) 95% 4.7 to 15.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.0 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -9.0 | |
Confidence Interval |
(2-Sided) 95% -14.9 to -3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.9 | |
Confidence Interval |
(2-Sided) 95% -2.1 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -6.3 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.0 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.5 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -6.4 to 4.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.3 | |
Confidence Interval |
(2-Sided) 95% -7.8 to 3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -9.6 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.6 | |
Confidence Interval |
(2-Sided) 95% -10.2 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.6 | |
Confidence Interval |
(2-Sided) 95% -1.0 to 9.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 7.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.6 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -6.4 to 5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.3 | |
Confidence Interval |
(2-Sided) 95% -2.2 to 8.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.9 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 7.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.3 | |
Confidence Interval |
(2-Sided) 95% -3.5 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 5.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.5 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 3.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.5 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -6.4 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -8.7 to 2.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 5.5 | |
Confidence Interval |
(2-Sided) 95% 0.3 to 10.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -3.2 to 7.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -6.1 to 4.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.4 | |
Confidence Interval |
(2-Sided) 95% -9.0 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.1 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -3.9 to 6.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.7 | |
Confidence Interval |
(2-Sided) 95% -4.7 to 6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -3.3 to 7.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.3 | |
Confidence Interval |
(2-Sided) 95% -5.7 to 4.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.9 | |
Confidence Interval |
(2-Sided) 95% -1.7 to 9.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -5.3 to 5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 3.8 | |
Confidence Interval |
(2-Sided) 95% -1.3 to 8.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.9 | |
Confidence Interval |
(2-Sided) 95% -4.3 to 6.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.9 | |
Confidence Interval |
(2-Sided) 95% -6.4 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.9 | |
Confidence Interval |
(2-Sided) 95% -10.8 to 0.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye |
---|---|
Description | Sub-RPE fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 4 |
25.4
|
24.2
|
29.2
|
Week 8 |
16.5
|
17.5
|
21.4
|
Week 12 |
13.7
|
14.2
|
21.1
|
Week 16 |
19.3
|
18.9
|
26.9
|
Week 20 |
19.8
|
20.6
|
17.8
|
Week 24 |
17.3
|
16.1
|
22.8
|
Week 28 |
18.7
|
15.6
|
18.3
|
Week 32 |
19.8
|
19.7
|
21.4
|
Week 36 |
12.8
|
13.1
|
18.1
|
Week 40 |
17.0
|
16.7
|
22.5
|
Week 44 |
16.2
|
13.9
|
18.1
|
Week 48 |
16.5
|
13.6
|
21.4
|
Week 52 |
12.8
|
12.8
|
13.9
|
Week 56 |
15.6
|
15.0
|
20.6
|
Week 60 |
12.6
|
13.1
|
15.3
|
Week 64 |
14.2
|
13.3
|
20.0
|
Week 68 |
13.7
|
14.2
|
15.3
|
Week 72 |
11.7
|
10.8
|
17.8
|
Week 76 |
12.0
|
12.5
|
13.3
|
Week 80 |
11.7
|
12.8
|
15.8
|
Week 84 |
11.5
|
11.7
|
16.7
|
Week 88 |
14.5
|
11.4
|
17.2
|
Week 92 |
12.6
|
10.3
|
13.1
|
Week 96 |
13.7
|
11.1
|
14.4
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.3 | |
Confidence Interval |
(2-Sided) 95% -7.7 to 3.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.7 | |
Confidence Interval |
(2-Sided) 95% -11.4 to 0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -9.3 to 1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.4 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.5 | |
Confidence Interval |
(2-Sided) 95% -11.5 to -1.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.6 | |
Confidence Interval |
(2-Sided) 95% -12.8 to -2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.5 | |
Confidence Interval |
(2-Sided) 95% -11.8 to -1.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.6 | |
Confidence Interval |
(2-Sided) 95% -14.4 to -2.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.7 | |
Confidence Interval |
(2-Sided) 95% -2.8 to 8.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.1 | |
Confidence Interval |
(2-Sided) 95% -3.4 to 7.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.6 | |
Confidence Interval |
(2-Sided) 95% -9.7 to 0.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.1 | |
Confidence Interval |
(2-Sided) 95% -12.3 to -1.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.1 | |
Confidence Interval |
(2-Sided) 95% -4.2 to 6.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.2 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.7 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 5.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.4 | |
Confidence Interval |
(2-Sided) 95% -7.5 to 3.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.5 | |
Confidence Interval |
(2-Sided) 95% -9.5 to 0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.4 | |
Confidence Interval |
(2-Sided) 95% -10.6 to -0.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.6 | |
Confidence Interval |
(2-Sided) 95% -10.2 to 1.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.3 | |
Confidence Interval |
(2-Sided) 95% -12.2 to -0.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.2 | |
Confidence Interval |
(2-Sided) 95% -6.6 to 4.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.7 | |
Confidence Interval |
(2-Sided) 95% -10.0 to 0.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.0 | |
Confidence Interval |
(2-Sided) 95% -9.4 to 1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.1 | |
Confidence Interval |
(2-Sided) 95% -13.6 to -2.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.4 | |
Confidence Interval |
(2-Sided) 95% -5.1 to 4.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.6 | |
Confidence Interval |
(2-Sided) 95% -6.2 to 2.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.2 | |
Confidence Interval |
(2-Sided) 95% -9.4 to 1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.2 | |
Confidence Interval |
(2-Sided) 95% -11.5 to -0.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.3 | |
Confidence Interval |
(2-Sided) 95% -7.3 to 3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.7 | |
Confidence Interval |
(2-Sided) 95% -7.9 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.2 | |
Confidence Interval |
(2-Sided) 95% -10.5 to 0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.1 | |
Confidence Interval |
(2-Sided) 95% -12.5 to -1.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -6.0 to 4.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.3 | |
Confidence Interval |
(2-Sided) 95% -6.3 to 3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.4 | |
Confidence Interval |
(2-Sided) 95% -10.1 to -0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.3 | |
Confidence Interval |
(2-Sided) 95% -12.2 to -2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.8 | |
Confidence Interval |
(2-Sided) 95% -5.2 to 4.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -5.8 to 3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.4 | |
Confidence Interval |
(2-Sided) 95% -8.4 to 1.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.3 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 1.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.7 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 0.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.4 | |
Confidence Interval |
(2-Sided) 95% -10.4 to -0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.2 | |
Confidence Interval |
(2-Sided) 95% -7.4 to 3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.0 | |
Confidence Interval |
(2-Sided) 95% -11.0 to -1.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -4.9 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -7.6 to 1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -5.3 to 5.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -8.5 to 0.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye |
---|---|
Description | Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 4 |
47.8
|
47.2
|
54.7
|
Week 8 |
32.7
|
30.3
|
42.5
|
Week 12 |
26.0
|
24.2
|
34.4
|
Week 16 |
41.6
|
33.9
|
52.2
|
Week 20 |
45.3
|
44.4
|
33.3
|
Week 24 |
39.9
|
27.5
|
50.8
|
Week 28 |
36.9
|
31.4
|
35.3
|
Week 32 |
45.5
|
40.0
|
50.3
|
Week 36 |
28.8
|
25.6
|
34.7
|
Week 40 |
37.2
|
32.5
|
45.6
|
Week 44 |
38.3
|
32.2
|
32.2
|
Week 48 |
34.1
|
31.1
|
44.7
|
Week 52 |
30.7
|
24.7
|
29.7
|
Week 56 |
38.8
|
35.0
|
41.9
|
Week 60 |
27.1
|
23.6
|
30.8
|
Week 64 |
33.5
|
28.9
|
41.1
|
Week 68 |
34.1
|
29.2
|
26.9
|
Week 72 |
27.9
|
24.4
|
36.9
|
Week 76 |
28.8
|
25.3
|
28.6
|
Week 80 |
32.1
|
28.6
|
36.7
|
Week 84 |
26.3
|
23.9
|
28.3
|
Week 88 |
32.7
|
26.1
|
36.7
|
Week 92 |
29.9
|
22.8
|
25.8
|
Week 96 |
30.4
|
23.9
|
36.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.7 | |
Confidence Interval |
(2-Sided) 95% -14.1 to 0.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 4 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.4 | |
Confidence Interval |
(2-Sided) 95% -15.3 to -0.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -9.3 | |
Confidence Interval |
(2-Sided) 95% -16.6 to -2.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 8 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.1 | |
Confidence Interval |
(2-Sided) 95% -19.7 to -5.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.2 | |
Confidence Interval |
(2-Sided) 95% -14.8 to -1.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 12 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.2 | |
Confidence Interval |
(2-Sided) 95% -17.4 to -3.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0030 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.2 | |
Confidence Interval |
(2-Sided) 95% -17.3 to -2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 16 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -18.2 | |
Confidence Interval |
(2-Sided) 95% -25.3 to -10.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 9
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 12.0 | |
Confidence Interval |
(2-Sided) 95% 5.2 to 19.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 10
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 20 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 11.1 | |
Confidence Interval |
(2-Sided) 95% 3.8 to 18.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 11
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.6 | |
Confidence Interval |
(2-Sided) 95% -17.7 to -3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 12
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -23.2 | |
Confidence Interval |
(2-Sided) 95% -30.5 to -16.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 13
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.7 | |
Confidence Interval |
(2-Sided) 95% -4.8 to 9.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 14
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 28 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.9 | |
Confidence Interval |
(2-Sided) 95% -11.8 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 15
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.5 | |
Confidence Interval |
(2-Sided) 95% -12.0 to 3.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 16
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 32 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.3 | |
Confidence Interval |
(2-Sided) 95% -18.0 to -3.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 17
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -5.9 | |
Confidence Interval |
(2-Sided) 95% -12.5 to 0.8 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 18
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 36 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -9.2 | |
Confidence Interval |
(2-Sided) 95% -16.2 to -2.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 19
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.2 | |
Confidence Interval |
(2-Sided) 95% -15.7 to -0.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 20
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 40 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -13.0 | |
Confidence Interval |
(2-Sided) 95% -20.5 to -5.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 21
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 6.0 | |
Confidence Interval |
(2-Sided) 95% -0.8 to 13.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 22
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 44 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -7.5 to 6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 23
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0020 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.5 | |
Confidence Interval |
(2-Sided) 95% -17.4 to -3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 24
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0001 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -13.5 | |
Confidence Interval |
(2-Sided) 95% -20.7 to -6.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 25
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 1.0 | |
Confidence Interval |
(2-Sided) 95% -5.4 to 8.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 26
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 52 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.9 | |
Confidence Interval |
(2-Sided) 95% -11.8 to 1.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 27
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.2 | |
Confidence Interval |
(2-Sided) 95% -10.3 to 3.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 28
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 56 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.9 | |
Confidence Interval |
(2-Sided) 95% -14.1 to 0.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 29
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -10.1 to 3.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 30
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 60 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.1 | |
Confidence Interval |
(2-Sided) 95% -14.0 to -0.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 31
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -7.6 | |
Confidence Interval |
(2-Sided) 95% -14.7 to -0.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 32
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 64 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.1 | |
Confidence Interval |
(2-Sided) 95% -19.5 to -5.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 33
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 7.2 | |
Confidence Interval |
(2-Sided) 95% 0.3 to 13.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 34
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 68 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -4.9 to 8.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 35
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.9 | |
Confidence Interval |
(2-Sided) 95% -15.7 to -1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 36
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.5 | |
Confidence Interval |
(2-Sided) 95% -19.8 to -5.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 37
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 0.3 | |
Confidence Interval |
(2-Sided) 95% -5.9 to 7.2 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 38
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 76 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.4 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 2.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 39
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.4 | |
Confidence Interval |
(2-Sided) 95% -11.2 to 2.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 40
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 80 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -8.1 | |
Confidence Interval |
(2-Sided) 95% -15.3 to -1.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 41
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -2.1 | |
Confidence Interval |
(2-Sided) 95% -8.9 to 4.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 42
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 84 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -4.5 | |
Confidence Interval |
(2-Sided) 95% -11.2 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 43
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -10.8 to 3.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 44
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 88 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -10.3 | |
Confidence Interval |
(2-Sided) 95% -17.3 to -3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 45
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | 4.1 | |
Confidence Interval |
(2-Sided) 95% -2.3 to 11.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 46
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 92 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -3.0 | |
Confidence Interval |
(2-Sided) 95% -9.8 to 2.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 47
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -6.4 | |
Confidence Interval |
(2-Sided) 95% -13.2 to 0.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Statistical Analysis 48
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Difference in proportions |
Estimated Value | -12.9 | |
Confidence Interval |
(2-Sided) 95% -19.7 to -6.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method. |
Title | Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits |
---|---|
Description | Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. For each subject, the number of visits with SRF and/or IRF fluid is analyzed. |
Time Frame | Weeks 36, 40, 44, 48 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - LOCF |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
0 Visits |
154
|
171
|
153
|
1 Visit |
67
|
73
|
48
|
2 Visits |
47
|
39
|
39
|
3 Visits |
26
|
22
|
40
|
4 Visits |
64
|
55
|
60
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0574 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | Cochran-Mantel-Haenszel | |
Comments | CMH-test row mean score (scores=table) stratified by age categories (<75, ≥75 years) and baseline fluid status) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0012 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | Cochran-Mantel-Haenszel | |
Comments | CMH-test row mean score (scores=table) stratified by age categories (<75, ≥75 years) and baseline fluid status) |
Title | Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye |
---|---|
Description | A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% CI for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. |
Time Frame | Week 16 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - 'efficacy/safety' approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 353 | 346 | 344 |
Number (95% Confidence Interval) [percentage of subjects] |
28.0
|
24.0
|
34.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0331 |
Comments | 1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | difference in proportions |
Estimated Value | -6.5 | |
Confidence Interval |
(2-Sided) 95% -13.2 to 0.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for age categories (<75, >=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method. |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0013 |
Comments | 1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg | |
Method | Regression, Logistic | |
Comments | ||
Method of Estimation | Estimation Parameter | difference in proportions |
Estimated Value | -10.5 | |
Confidence Interval |
(2-Sided) 95% -17.1 to -3.5 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Statistical model used logistic regression adjusting for age categories (<75, >=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method. |
Title | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96 |
---|---|
Description | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from age-related macular degeneration (AMD) subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning. |
Time Frame | Baseline, Weeks 24, 48, 72, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Change from baseline at Week 24 |
4.4
(10.49)
|
4.0
(12.20)
|
3.5
(9.97)
|
Change from baseline at Week 48 |
4.3
(11.44)
|
4.1
(12.58)
|
4.5
(10.64)
|
Change from baseline at Week 72 |
4.4
(12.19)
|
3.9
(12.53)
|
4.0
(12.05)
|
Change from baseline at Week 96 |
3.8
(13.53)
|
3.8
(13.50)
|
2.8
(13.28)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | 0.90 | |
Confidence Interval |
(2-Sided) 95% -0.5 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 24 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | 0.63 | |
Confidence Interval |
(2-Sided) 95% -0.9 to 2.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | -0.20 | |
Confidence Interval |
(2-Sided) 95% -1.8 to 1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 48 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | -0.26 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.4 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | 0.18 | |
Confidence Interval |
(2-Sided) 95% -1.6 to 1.9 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 72 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | -0.12 | |
Confidence Interval |
(2-Sided) 95% -1.9 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Statistical Analysis 7
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 3 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | 0.75 | |
Confidence Interval |
(2-Sided) 95% -1.2 to 2.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg) |
Statistical Analysis 8
Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
---|---|---|
Comments | Week 96 | |
Type of Statistical Test | Other | |
Comments | Treatment difference | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Least squares mean difference |
Estimated Value | 1.05 | |
Confidence Interval |
(2-Sided) 95% -0.9 to 3.0 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg) |
Title | Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only) |
---|---|
Description | Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. Hypothesis testing not pre-specified. |
Time Frame | Week 48 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Analysis Set - Observed. All randomized subjects who received at least 1 intravitreal injection. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 356 | 353 | 348 |
Number [percentage of subjects] |
25.6
|
20.4
|
65.8
|
Title | Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye |
---|---|
Description | Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified. |
Time Frame | Baseline, Weeks 12, 48, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 12 |
0.0
|
0.3
|
0.9
|
Week 48 |
0.0
|
0.0
|
0.0
|
Week 96 |
0.3
|
0.0
|
0.0
|
Title | Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye |
---|---|
Description | Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified. |
Time Frame | Baseline, Weeks 12, 48, 96 |
Outcome Measure Data
Analysis Population Description |
---|
FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit. |
Arm/Group Title | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg |
---|---|---|---|
Arm/Group Description | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit | Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit | Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
Measure Participants | 358 | 360 | 360 |
Week 12 |
1.6
|
2.4
|
0.7
|
Week 48 |
1.8
|
0.4
|
2.6
|
Week 96 |
0.7
|
0.8
|
1.6
|
Adverse Events
Time Frame | First treatment through study completion, an average of 96 weeks | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set). | |||||
Arm/Group Title | Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | |||
Arm/Group Description | All subjects exposed to brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose | All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose | All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose | |||
All Cause Mortality |
||||||
Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 9/358 (2.5%) | 8/360 (2.2%) | 12/360 (3.3%) | |||
Serious Adverse Events |
||||||
Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 94/358 (26.3%) | 95/360 (26.4%) | 114/360 (31.7%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Anaemia megaloblastic | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Coagulopathy | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cardiac disorders | ||||||
Acute left ventricular failure | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Acute myocardial infarction | 2/358 (0.6%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Angina pectoris | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Angina unstable | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Aortic valve incompetence | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Arrhythmia | 0/358 (0%) | 2/360 (0.6%) | 1/360 (0.3%) | |||
Atrial fibrillation | 4/358 (1.1%) | 4/360 (1.1%) | 2/360 (0.6%) | |||
Atrial flutter | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Atrioventricular block | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Atrioventricular block second degree | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cardiac arrest | 1/358 (0.3%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Cardiac disorder | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cardiac failure | 1/358 (0.3%) | 0/360 (0%) | 2/360 (0.6%) | |||
Cardiac failure congestive | 4/358 (1.1%) | 6/360 (1.7%) | 4/360 (1.1%) | |||
Cardiac ventricular thrombosis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Cardio-respiratory arrest | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Cardiogenic shock | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Coronary artery disease | 6/358 (1.7%) | 1/360 (0.3%) | 3/360 (0.8%) | |||
Coronary artery occlusion | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Left ventricular failure | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Mitral valve incompetence | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Myocardial infarction | 1/358 (0.3%) | 2/360 (0.6%) | 3/360 (0.8%) | |||
Palpitations | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Pericardial effusion | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Ventricular tachycardia | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Congenital, familial and genetic disorders | ||||||
Endocardial fibroelastosis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Eye disorders | ||||||
Cataract - Fellow eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cataract - Study eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cataract subcapsular - Study eye | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Glaucoma - Study eye | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Macular hole - Study eye | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Neovascular age-related macular degeneration - Fellow eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Retinal artery occlusion - Study eye | 3/358 (0.8%) | 0/360 (0%) | 0/360 (0%) | |||
Retinal artery thrombosis - Study eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Retinal depigmentation - Study eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Retinal detachment - Study eye | 1/358 (0.3%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Retinal haemorrhage - Fellow eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Retinopathy proliferative - Study eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Uveitis - Study eye | 1/358 (0.3%) | 2/360 (0.6%) | 0/360 (0%) | |||
Visual acuity reduced - Study eye | 0/358 (0%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Vitritis - Study eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Gastrointestinal disorders | ||||||
Abdominal hernia | 0/358 (0%) | 0/360 (0%) | 2/360 (0.6%) | |||
Abdominal pain | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Acute abdomen | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Colitis ischaemic | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Colitis microscopic | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Constipation | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Diverticulum intestinal haemorrhagic | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Duodenal ulcer haemorrhage | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Gastrointestinal haemorrhage | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Haemorrhoids | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Hiatus hernia | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Inguinal hernia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Intestinal obstruction | 1/358 (0.3%) | 0/360 (0%) | 3/360 (0.8%) | |||
Intestinal perforation | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Large intestinal haemorrhage | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Large intestine polyp | 0/358 (0%) | 2/360 (0.6%) | 1/360 (0.3%) | |||
Lower gastrointestinal haemorrhage | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Nausea | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Oesophageal stenosis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Pancreatitis | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Rectal haemorrhage | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Rectal polyp | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Retroperitoneal haemorrhage | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Small intestinal perforation | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Umbilical hernia | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Vomiting | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
General disorders | ||||||
Asthenia | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Chest pain | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Death | 1/358 (0.3%) | 0/360 (0%) | 2/360 (0.6%) | |||
Mass | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Non-cardiac chest pain | 1/358 (0.3%) | 1/360 (0.3%) | 3/360 (0.8%) | |||
Pyrexia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hepatobiliary disorders | ||||||
Bile duct obstruction | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Bile duct stone | 2/358 (0.6%) | 0/360 (0%) | 0/360 (0%) | |||
Cholangitis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Cholecystitis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Cholecystitis acute | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Cholelithiasis | 4/358 (1.1%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Hepatic failure | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Hepatitis acute | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Immune system disorders | ||||||
Anaphylactic reaction | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Infections and infestations | ||||||
Abscess oral | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Abscess soft tissue | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Appendicitis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Bronchitis | 2/358 (0.6%) | 0/360 (0%) | 1/360 (0.3%) | |||
Cellulitis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Device related infection | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Endophthalmitis - Study eye | 3/358 (0.8%) | 3/360 (0.8%) | 0/360 (0%) | |||
Escherichia infection | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Escherichia urinary tract infection | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
H1N1 influenza | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Herpes zoster | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Influenza | 3/358 (0.8%) | 0/360 (0%) | 1/360 (0.3%) | |||
Kidney infection | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Necrotising fasciitis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Osteomyelitis | 0/358 (0%) | 0/360 (0%) | 2/360 (0.6%) | |||
Perineal cellulitis | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Pharyngitis | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Pneumonia | 7/358 (2%) | 10/360 (2.8%) | 9/360 (2.5%) | |||
Pneumonia bacterial | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Pyelonephritis | 2/358 (0.6%) | 0/360 (0%) | 0/360 (0%) | |||
Pyelonephritis acute | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Respiratory tract infection | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Sepsis | 3/358 (0.8%) | 4/360 (1.1%) | 1/360 (0.3%) | |||
Septic shock | 0/358 (0%) | 3/360 (0.8%) | 0/360 (0%) | |||
Urinary tract infection | 4/358 (1.1%) | 2/360 (0.6%) | 2/360 (0.6%) | |||
Injury, poisoning and procedural complications | ||||||
Accidental overdose | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Cervical vertebral fracture | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Concussion | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Contusion | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Face injury | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Facial bones fracture - Fellow eye | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Fall | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Femoral neck fracture | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Femur fracture | 0/358 (0%) | 2/360 (0.6%) | 4/360 (1.1%) | |||
Forearm fracture | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Head injury | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Hip fracture | 1/358 (0.3%) | 0/360 (0%) | 2/360 (0.6%) | |||
Ilium fracture | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Incisional hernia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Lower limb fracture | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Neck injury | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Overdose | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Pubis fracture | 2/358 (0.6%) | 0/360 (0%) | 1/360 (0.3%) | |||
Rib fracture | 0/358 (0%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Spinal fracture | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Sternal fracture | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Subarachnoid haemorrhage | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Subdural haematoma | 1/358 (0.3%) | 1/360 (0.3%) | 3/360 (0.8%) | |||
Toxicity to various agents | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Traumatic haematoma | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Ulna fracture | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Wrist fracture | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Investigations | ||||||
Blood parathyroid hormone increased | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Blood pressure increased | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Platelet count decreased | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Metabolism and nutrition disorders | ||||||
Dehydration | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Fluid retention | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hyperkalaemia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hypervolaemia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hypoglycaemia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hyponatraemia | 4/358 (1.1%) | 2/360 (0.6%) | 1/360 (0.3%) | |||
Malnutrition | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Metabolic disorder | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Arthritis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Back pain | 0/358 (0%) | 2/360 (0.6%) | 1/360 (0.3%) | |||
Chondrocalcinosis pyrophosphate | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Intervertebral disc protrusion | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Osteoarthritis | 2/358 (0.6%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Rotator cuff syndrome | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Soft tissue mass | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Spinal column stenosis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Spondylolisthesis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
B-cell small lymphocytic lymphoma | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Bladder cancer | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Brain neoplasm | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Colon cancer | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Diffuse large B-cell lymphoma | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Gastric adenoma | 0/358 (0%) | 0/360 (0%) | 2/360 (0.6%) | |||
Gastric cancer | 2/358 (0.6%) | 1/360 (0.3%) | 0/360 (0%) | |||
Hepatic cancer | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Invasive ductal breast carcinoma | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Lung adenocarcinoma | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Lung cancer metastatic | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Lung carcinoma cell type unspecified stage IV | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Lung neoplasm malignant | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Lymphoma | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Malignant melanoma | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Mantle cell lymphoma recurrent | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Metastatic neoplasm | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Neoplasm malignant | 1/358 (0.3%) | 0/360 (0%) | 2/360 (0.6%) | |||
Non-small cell lung cancer | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Pancreatic carcinoma metastatic | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Prostate cancer | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Prostate cancer metastatic | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Rectal adenocarcinoma | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Renal cell carcinoma | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Squamous cell carcinoma of the hypopharynx | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Squamous cell carcinoma of the oral cavity | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Nervous system disorders | ||||||
Amnesia | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Carotid artery occlusion | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Carotid artery stenosis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Cerebral haemorrhage | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Cerebral infarction | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Cerebrovascular accident | 3/358 (0.8%) | 4/360 (1.1%) | 3/360 (0.8%) | |||
Dementia | 2/358 (0.6%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Encephalopathy | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Haemorrhagic cerebral infarction | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Headache | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Hypoaesthesia | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Intracranial aneurysm | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Ischaemic stroke | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Lacunar infarction | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Lumbar radiculopathy | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Lumbosacral radiculopathy | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Neurological decompensation | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Presyncope | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Sciatica | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Seizure | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Syncope | 3/358 (0.8%) | 2/360 (0.6%) | 3/360 (0.8%) | |||
Transient ischaemic attack | 3/358 (0.8%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
VIth nerve paralysis - Fellow eye | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Product Issues | ||||||
Device dislocation | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Device failure | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Psychiatric disorders | ||||||
Anxiety | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Delirium | 2/358 (0.6%) | 0/360 (0%) | 0/360 (0%) | |||
Major depression | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Mental status changes | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Psychotic disorder | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Schizophrenia | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Suicide attempt | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Renal and urinary disorders | ||||||
Acute kidney injury | 0/358 (0%) | 2/360 (0.6%) | 0/360 (0%) | |||
Chronic kidney disease | 2/358 (0.6%) | 0/360 (0%) | 1/360 (0.3%) | |||
Glomerulonephritis | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Haematuria | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Nephrolithiasis | 1/358 (0.3%) | 2/360 (0.6%) | 2/360 (0.6%) | |||
Renal cyst | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Renal failure | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Ureterolithiasis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Reproductive system and breast disorders | ||||||
Benign prostatic hyperplasia | 0/358 (0%) | 2/360 (0.6%) | 1/360 (0.3%) | |||
Prostatitis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Acute respiratory failure | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Chronic obstructive pulmonary disease | 1/358 (0.3%) | 6/360 (1.7%) | 4/360 (1.1%) | |||
Dyspnoea | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Dyspnoea exertional | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Emphysema | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Mediastinal haematoma | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Pleural effusion | 1/358 (0.3%) | 0/360 (0%) | 1/360 (0.3%) | |||
Pneumothorax | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Pulmonary embolism | 2/358 (0.6%) | 0/360 (0%) | 1/360 (0.3%) | |||
Pulmonary hypertension | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Pulmonary oedema | 1/358 (0.3%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Respiratory failure | 0/358 (0%) | 2/360 (0.6%) | 2/360 (0.6%) | |||
Surgical and medical procedures | ||||||
Hospitalisation | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Mass excision | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Vascular disorders | ||||||
Aortic stenosis | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Arteriosclerosis | 0/358 (0%) | 1/360 (0.3%) | 0/360 (0%) | |||
Deep vein thrombosis | 0/358 (0%) | 1/360 (0.3%) | 2/360 (0.6%) | |||
Embolism venous | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Haematoma | 0/358 (0%) | 1/360 (0.3%) | 1/360 (0.3%) | |||
Hypertension | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Hypertensive crisis | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Inferior vena caval occlusion | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Intermittent claudication | 0/358 (0%) | 0/360 (0%) | 1/360 (0.3%) | |||
Peripheral arterial occlusive disease | 1/358 (0.3%) | 0/360 (0%) | 0/360 (0%) | |||
Peripheral ischaemia | 1/358 (0.3%) | 1/360 (0.3%) | 0/360 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Brolucizumab 3mg | Brolucizumab 6mg | Aflibercept 2mg | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 239/358 (66.8%) | 228/360 (63.3%) | 228/360 (63.3%) | |||
Eye disorders | ||||||
Cataract - Study eye | 18/358 (5%) | 19/360 (5.3%) | 13/360 (3.6%) | |||
Conjunctival haemorrhage - Study eye | 39/358 (10.9%) | 29/360 (8.1%) | 32/360 (8.9%) | |||
Dry eye - Fellow eye | 16/358 (4.5%) | 15/360 (4.2%) | 24/360 (6.7%) | |||
Dry eye - Study eye | 20/358 (5.6%) | 19/360 (5.3%) | 26/360 (7.2%) | |||
Eye pain - Study eye | 28/358 (7.8%) | 18/360 (5%) | 21/360 (5.8%) | |||
Neovascular age-related macular degeneration - Fellow eye | 33/358 (9.2%) | 32/360 (8.9%) | 31/360 (8.6%) | |||
Retinal haemorrhage - Study eye | 14/358 (3.9%) | 21/360 (5.8%) | 20/360 (5.6%) | |||
Visual acuity reduced - Study eye | 34/358 (9.5%) | 21/360 (5.8%) | 27/360 (7.5%) | |||
Vitreous detachment - Study eye | 24/358 (6.7%) | 19/360 (5.3%) | 19/360 (5.3%) | |||
Vitreous floaters - Study eye | 26/358 (7.3%) | 22/360 (6.1%) | 16/360 (4.4%) | |||
Infections and infestations | ||||||
Bronchitis | 12/358 (3.4%) | 13/360 (3.6%) | 21/360 (5.8%) | |||
Influenza | 15/358 (4.2%) | 17/360 (4.7%) | 20/360 (5.6%) | |||
Nasopharyngitis | 44/358 (12.3%) | 38/360 (10.6%) | 44/360 (12.2%) | |||
Pneumonia | 10/358 (2.8%) | 23/360 (6.4%) | 13/360 (3.6%) | |||
Urinary tract infection | 39/358 (10.9%) | 26/360 (7.2%) | 40/360 (11.1%) | |||
Injury, poisoning and procedural complications | ||||||
Fall | 18/358 (5%) | 8/360 (2.2%) | 7/360 (1.9%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 19/358 (5.3%) | 15/360 (4.2%) | 21/360 (5.8%) | |||
Back pain | 26/358 (7.3%) | 13/360 (3.6%) | 17/360 (4.7%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 20/358 (5.6%) | 13/360 (3.6%) | 17/360 (4.7%) | |||
Vascular disorders | ||||||
Hypertension | 33/358 (9.2%) | 25/360 (6.9%) | 23/360 (6.4%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Novartis Pharmaceuticals |
Phone | 1-862-778-8300 |
novartis.email@novartis.com |
- RTH258-C001
- CRTH258A2301