HAWK: Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT02307682
Collaborator
(none)
1,775
1
3
39.6
44.8

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
  • Drug: Brolucizumab ophthalmic solution
  • Drug: Aflibercept ophthalmic solution
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

Study Type:
Interventional
Actual Enrollment :
1775 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 Versus Aflibercept in Subjects With Neovascular Age-Related Macular Degeneration
Actual Study Start Date :
Dec 8, 2014
Actual Primary Completion Date :
Apr 22, 2017
Actual Study Completion Date :
Mar 28, 2018

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:
  • RTH258
  • 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:
  • RTH258
  • 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:
  • EYLEA®
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    15. 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.

    16. 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.

    17. 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.

    18. 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.

    19. 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.

    20. 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.

    21. 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.

    22. 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.

    23. 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.

    24. 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.

    25. 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.

    26. 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.

    27. 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.

    28. 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.

    29. 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.

    30. 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.

    31. 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.

    32. 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

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02307682
    Other Study ID Numbers:
    • RTH258-C001
    • CRTH258A2301
    First Posted:
    Dec 4, 2014
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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)
    3. Secondary Outcome
    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
    4. Secondary Outcome
    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
    5. Secondary Outcome
    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
    6. Secondary Outcome
    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
    7. Secondary Outcome
    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)
    8. Secondary Outcome
    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)
    9. Secondary Outcome
    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)
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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.
    12. Secondary Outcome
    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.
    13. Secondary Outcome
    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.
    14. Secondary Outcome
    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.
    15. Secondary Outcome
    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.
    16. Secondary Outcome
    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.
    17. Secondary Outcome
    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.
    18. Secondary Outcome
    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)
    19. Secondary Outcome
    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)
    20. Secondary Outcome
    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)
    21. Secondary Outcome
    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)
    22. Secondary Outcome
    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)
    23. Secondary Outcome
    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)
    24. Secondary Outcome
    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.
    25. Secondary Outcome
    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.
    26. Secondary Outcome
    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.
    27. Secondary Outcome
    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.
    28. Secondary Outcome
    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)
    29. Secondary Outcome
    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.
    30. Secondary Outcome
    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)
    31. Secondary Outcome
    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
    32. Secondary Outcome
    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
    33. Secondary Outcome
    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

    [Not Specified]

    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
    Email novartis.email@novartis.com
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT02307682
    Other Study ID Numbers:
    • RTH258-C001
    • CRTH258A2301
    First Posted:
    Dec 4, 2014
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Oct 1, 2019