RAPTOR: Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT03802630
Collaborator
(none)
450
102
2
24.8
4.4
0.2
Study Details
Study Description
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The study was comprised of a Screening period (Day -28 to Day -1), Double-masked treatment period (Day 1 to Week 72) and Post-treatment follow-up period (Week 72 to Week 76). Treatment visits were scheduled in 4-week intervals. After 6 initial monthly injections of brolucizumab or aflibercept (loading phase), subjects entered a one-year individualized flexible treatment (IFT) phase. During the IFT phase, an assessment of disease stability was performed at each monthly visit and subjects received either an active or a sham injection. Treatment with active was interrupted when disease stability was reached.
Study Design
Study Type:
Interventional
Actual Enrollment
:
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
A masked evaluating investigator was responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator performed the injections and assessed patient safety following the injections.
Primary Purpose:
Treatment
Official Title:
An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion
Actual Study Start Date
:
Jul 2, 2019
Actual Primary Completion Date
:
Jul 26, 2021
Actual Study Completion Date
:
Jul 26, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brolucizumab 6 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
Drug: Brolucizumab 6 mg
Solution for injection (intravitreal use)
Other Names:
Other: Sham injection
Empty sterile syringe without a needle administered as a sham injection for masking purposes.
From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.
|
| Active Comparator: Aflibercept 2 mg 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
Drug: Aflibercept 2 mg
Solution for injection (Intravitreal use)
Other Names:
Other: Sham injection
Empty sterile syringe without a needle administered as a sham injection for masking purposes.
From Week 24 to Week 72 inclusive, a sham treatment was performed to maintain subject masking in case treatment with brolucizumab or aflibercept was not deemed necessary by the investigator.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 [Baseline, Week 24]
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward.
Secondary Outcome Measures
- Change From Baseline in BCVA Averaged Over Week 40 to Week 52 [Baseline, Week 40 to Week 52]
An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
- Change From Baseline in BCVA Averaged Over Week 64 to Week 76 [Baseline, Week 64 to Week 76]
An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
- Change From Baseline in BCVA by Visit up to Week 76 [Baseline and every 4 weeks from baseline up to Week 76]
BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
- Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline [Baseline and every 4 weeks from baseline up to Week 76]
The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
- Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline [Baseline and every 4 weeks from baseline up to Week 76]
The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart.
- Change From Baseline in CSFT Averaged Over Week 40 to Week 52 [Baseline, Week 40 to Week 52]
Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Change From Baseline in CSFT Averaged Over Week 64 to Week 76 [Baseline, Week 64 to Week 76]
Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Change From Baseline in CSFT by Visit up to Week 76 [Baseline, and every 4 weeks from baseline up to Week 76]
Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 [Every 4 weeks from baseline up to Week 76]
Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 [Every 4 weeks from Week 4 up to Week 76]
Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 [Week 24 to Week 52 and Week 24 to Week 72]
Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented
- Time to Recurrence After Week 20 and up to Week 76 [Week 20 to Week 76]
Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76. For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1).
- Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 [Baseline to Week 76]
Number of subjects with at least one ocular or non-ocular Adverse Events (AEs).
- Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 [Baseline, Week 24, Week 52 and Week 76]
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL). The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life.
- Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 [Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76]
Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Signed informed consent must be obtained prior to participation in the study.
-
Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening.
-
BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.
Exclusion criteria
-
Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded.
-
Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
-
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline
-
Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
-
Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline
-
Previous use of intraocular or periocular steroids in study eye at any time prior to baseline
-
Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline
-
Intraocular surgery in the study eye during the 3-month period prior to baseline
-
Vitreoretinal surgery in the study eye at any time prior to baseline
-
Aphakia with the absence of posterior capsule in the study eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Phoenix | Arizona | United States | 85020 |
| 2 | Novartis Investigative Site | Mountain View | California | United States | 94040 |
| 3 | Novartis Investigative Site | Santa Barbara | California | United States | 93103 |
| 4 | Novartis Investigative Site | Colorado Springs | Colorado | United States | 80909 |
| 5 | Novartis Investigative Site | Pensacola | Florida | United States | 32503 |
| 6 | Novartis Investigative Site | Saint Petersburg | Florida | United States | 33711 |
| 7 | Novartis Investigative Site | Indianapolis | Indiana | United States | 46280 |
| 8 | Novartis Investigative Site | New Albany | Indiana | United States | 47150 |
| 9 | Novartis Investigative Site | Leawood | Kansas | United States | 66211 |
| 10 | Novartis Investigative Site | Lenexa | Kansas | United States | 66215 |
| 11 | Novartis Investigative Site | Stoneham | Massachusetts | United States | 02180 |
| 12 | Novartis Investigative Site | Reno | Nevada | United States | 89502 |
| 13 | Novartis Investigative Site | Bloomfield | New Jersey | United States | 07003 |
| 14 | Novartis Investigative Site | Asheville | North Carolina | United States | 28803 |
| 15 | Novartis Investigative Site | Charlotte | North Carolina | United States | 28210 |
| 16 | Novartis Investigative Site | Cleveland | Ohio | United States | 44122 |
| 17 | Novartis Investigative Site | Monroeville | Pennsylvania | United States | 15146 |
| 18 | Novartis Investigative Site | Abilene | Texas | United States | 79606 |
| 19 | Novartis Investigative Site | Arlington | Texas | United States | 76012 |
| 20 | Novartis Investigative Site | Austin | Texas | United States | 78731 |
| 21 | Novartis Investigative Site | Austin | Texas | United States | 78750 |
| 22 | Novartis Investigative Site | Bellaire | Texas | United States | 77401 |
| 23 | Novartis Investigative Site | Houston | Texas | United States | 77025 |
| 24 | Novartis Investigative Site | Houston | Texas | United States | 77030 |
| 25 | Novartis Investigative Site | San Antonio | Texas | United States | 78240 |
| 26 | Novartis Investigative Site | Madison | Wisconsin | United States | 53705-3611 |
| 27 | Novartis Investigative Site | Graz | Austria | A-8036 | |
| 28 | Novartis Investigative Site | Calgary | Alberta | Canada | T2H0C8 |
| 29 | Novartis Investigative Site | London | Ontario | Canada | N6A 4V2 |
| 30 | Novartis Investigative Site | Ottawa | Ontario | Canada | K1Z 8R2 |
| 31 | Novartis Investigative Site | Toronto | Ontario | Canada | M5T 2S8 |
| 32 | Novartis Investigative Site | Quebec | Canada | G1S 4L8 | |
| 33 | Novartis Investigative Site | Guangzhou | Guangdong | China | 510060 |
| 34 | Novartis Investigative Site | Wuhan | Hubei | China | 430070 |
| 35 | Novartis Investigative Site | Wuxi | Jiangsu | China | 214002 |
| 36 | Novartis Investigative Site | Chengdu | Sichuan | China | 610041 |
| 37 | Novartis Investigative Site | Tianjin | Tianjin | China | 300020 |
| 38 | Novartis Investigative Site | Tianjin | Tianjin | China | 300070 |
| 39 | Novartis Investigative Site | Wenzhou | Zhejiang | China | 325027 |
| 40 | Novartis Investigative Site | Beijing | China | 100044 | |
| 41 | Novartis Investigative Site | Beijing | China | 100730 | |
| 42 | Novartis Investigative Site | Chongqing | China | 400038 | |
| 43 | Novartis Investigative Site | Shanghai | China | 200080 | |
| 44 | Novartis Investigative Site | Pardubice | Czechia | 532 03 | |
| 45 | Novartis Investigative Site | Praha 10 | Czechia | 100 34 | |
| 46 | Novartis Investigative Site | Praha | Czechia | 12808 | |
| 47 | Novartis Investigative Site | Copenhagen | Denmark | 2100 | |
| 48 | Novartis Investigative Site | Strasbourg | Bas Rhin | France | 67000 |
| 49 | Novartis Investigative Site | Saint Cyr sur Loire | Indre Et Loire | France | 37540 |
| 50 | Novartis Investigative Site | Bordeaux | France | 33000 | |
| 51 | Novartis Investigative Site | Creteil | France | 94000 | |
| 52 | Novartis Investigative Site | Dijon | France | 21034 | |
| 53 | Novartis Investigative Site | Marseille | France | F 13008 | |
| 54 | Novartis Investigative Site | Paris cedex 10 | France | 75010 | |
| 55 | Novartis Investigative Site | Paris | France | 75015 | |
| 56 | Novartis Investigative Site | Regensburg | Bavaria | Germany | 93053 |
| 57 | Novartis Investigative Site | Bonn | Germany | 53105 | |
| 58 | Novartis Investigative Site | Duesseldorf | Germany | 40212 | |
| 59 | Novartis Investigative Site | Freiburg | Germany | 79106 | |
| 60 | Novartis Investigative Site | Gottingen | Germany | 37075 | |
| 61 | Novartis Investigative Site | Leipzig | Germany | 04103 | |
| 62 | Novartis Investigative Site | Ludwigshafen | Germany | 67063 | |
| 63 | Novartis Investigative Site | Mainz | Germany | 55131 | |
| 64 | Novartis Investigative Site | Muenster | Germany | 48145 | |
| 65 | Novartis Investigative Site | Ulm | Germany | 89075 | |
| 66 | Novartis Investigative Site | Hongkong | Hong Kong | ||
| 67 | Novartis Investigative Site | Jerusalem | Israel | 91031 | |
| 68 | Novartis Investigative Site | Petach Tikva | Israel | 4941492 | |
| 69 | Novartis Investigative Site | Zerifin | Israel | 6093000 | |
| 70 | Novartis Investigative Site | Catania | CT | Italy | 95123 |
| 71 | Novartis Investigative Site | Pisa | PI | Italy | 56124 |
| 72 | Novartis Investigative Site | Roma | RM | Italy | 00133 |
| 73 | Novartis Investigative Site | Roma | RM | Italy | 00198 |
| 74 | Novartis Investigative Site | Udine | UD | Italy | 33100 |
| 75 | Novartis Investigative Site | Nagoya-city | Aichi | Japan | 467-8602 |
| 76 | Novartis Investigative Site | Amagasaki city | Hyogo | Japan | 660 8550 |
| 77 | Novartis Investigative Site | Ishioka | Ibaraki | Japan | 315-0037 |
| 78 | Novartis Investigative Site | Chiyoda-ku | Tokyo | Japan | 101-8309 |
| 79 | Novartis Investigative Site | Taito-ku | Tokyo | Japan | 111-0051 |
| 80 | Novartis Investigative Site | Osaka | Japan | 543-0027 | |
| 81 | Novartis Investigative Site | Arecibo | Puerto Rico | 00612 | |
| 82 | Novartis Investigative Site | Cheboksary | Russian Federation | 428028 | |
| 83 | Novartis Investigative Site | Moscow | Russian Federation | 119021 | |
| 84 | Novartis Investigative Site | Saratov | Russian Federation | 410012 | |
| 85 | Novartis Investigative Site | Sterlitamak | Russian Federation | 453128 | |
| 86 | Novartis Investigative Site | Bratislava | Slovakia | 85107 | |
| 87 | Novartis Investigative Site | Nitra | Slovakia | 950 01 | |
| 88 | Novartis Investigative Site | Zvolen | Slovakia | 960 01 | |
| 89 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
| 90 | Novartis Investigative Site | Sant Cugat | Catalunya | Spain | 08190 |
| 91 | Novartis Investigative Site | Santiago de Compostela | Galicia | Spain | 15706 |
| 92 | Novartis Investigative Site | Barcelona | Spain | 08021 | |
| 93 | Novartis Investigative Site | Madrid | Spain | 28040 | |
| 94 | Novartis Investigative Site | Lausanne | Vaud | Switzerland | 1006 |
| 95 | Novartis Investigative Site | Binningen | Switzerland | 4102 | |
| 96 | Novartis Investigative Site | Changhua | Taiwan | 50006 | |
| 97 | Novartis Investigative Site | Taipei | Taiwan | 10002 | |
| 98 | Novartis Investigative Site | Westcliff-on-Sea | Essex | United Kingdom | SS0 0RY |
| 99 | Novartis Investigative Site | Bradford | West Yorkshire | United Kingdom | BD9 6RJ |
| 100 | Novartis Investigative Site | Birmingham | United Kingdom | B18 7QH | |
| 101 | Novartis Investigative Site | Liverpool | United Kingdom | L7 8XP | |
| 102 | Novartis Investigative Site | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03802630
Other Study ID Numbers:
- CRTH258C2301
- 2018-001842-33
First Posted:
Jan 14, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from 103 sites in 18 countries |
|---|---|
| Pre-assignment Detail | The study comprised a screening period of 28 days |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Period Title: Overall Study | ||
| STARTED | 226 | 224 |
| COMPLETED | 73 | 76 |
| NOT COMPLETED | 153 | 148 |
Baseline Characteristics
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | Total of all reporting groups |
| Overall Participants | 226 | 224 | 450 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
65.4
(11.05)
|
65.0
(10.92)
|
65.2
(10.97)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
117
51.8%
|
125
55.8%
|
242
53.8%
|
| Male |
109
48.2%
|
99
44.2%
|
208
46.2%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| White |
154
68.1%
|
153
68.3%
|
307
68.2%
|
| Black or African American |
8
3.5%
|
4
1.8%
|
12
2.7%
|
| Asian |
65
28.8%
|
67
29.9%
|
132
29.3%
|
Outcome Measures
| Title | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 |
|---|---|
| Description | BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Missing and censored BCVA values were imputed by Last observation carried forward (LOCF) as the primary approach. Observed values from both scheduled and unscheduled post-baseline visits were used for the LOCF imputation. For subjects with no post-baseline BCVA value, the baseline value was carried forward. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) included all randomized subjects who received at least one Intravitreal injection of the study treatment. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Least Squares Mean (Standard Error) [Letters read] |
13.1
(0.71)
|
15.0
(0.71)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Brolucizumab 6 mg, Aflibercept 2 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters. | |
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean Difference |
| Estimated Value | -1.9 | |
| Confidence Interval |
(2-Sided) 95% -3.9 to 0.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.01 |
|
| Estimation Comments | ||
| Title | Change From Baseline in BCVA Averaged Over Week 40 to Week 52 |
|---|---|
| Description | An average BCVA over week 40 to week 52 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Time Frame | Baseline, Week 40 to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 123 | 132 |
| Mean (Standard Deviation) [Letters read] |
12.9
(12.81)
|
16.9
(10.63)
|
| Title | Change From Baseline in BCVA Averaged Over Week 64 to Week 76 |
|---|---|
| Description | An average BCVA over week 64 to week 76 was calculated. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Time Frame | Baseline, Week 64 to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline period. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 110 | 121 |
| Mean (Standard Deviation) [Letters read] |
13.7
(13.33)
|
17.9
(10.65)
|
| Title | Change From Baseline in BCVA by Visit up to Week 76 |
|---|---|
| Description | BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. |
| Time Frame | Baseline and every 4 weeks from baseline up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4 |
9.2
(8.22)
|
10.3
(10.13)
|
| Week 8 |
11.9
(10.68)
|
12.8
(10.84)
|
| Week 12 |
13.2
(10.22)
|
14.8
(11.23)
|
| Week 16 |
12.2
(12.59)
|
16.3
(11.58)
|
| Week 20 |
13.5
(10.83)
|
16.3
(12.15)
|
| Week 24 |
12.7
(12.36)
|
16.6
(11.35)
|
| Week 28 |
12.1
(13.88)
|
16.4
(10.62)
|
| Week 32 |
12.2
(13.24)
|
15.7
(10.94)
|
| Week 36 |
11.8
(14.75)
|
16.9
(10.95)
|
| Week 40 |
12.7
(12.89)
|
16.9
(10.74)
|
| Week 44 |
13.5
(13.28)
|
17.2
(11.37)
|
| Week 48 |
13.3
(13.38)
|
17.7
(10.79)
|
| Week 52 |
13.5
(13.42)
|
17.2
(10.46)
|
| Week 56 |
14.9
(10.86)
|
17.7
(10.62)
|
| Week 60 |
13.7
(13.67)
|
17.7
(10.33)
|
| Week 64 |
14.1
(13.72)
|
18.0
(10.54)
|
| Week 68 |
13.9
(13.83)
|
17.7
(10.75)
|
| Week 72 |
13.9
(13.38)
|
18.4
(11.44)
|
| Week 76 |
14.4
(13.72)
|
18.1
(11.19)
|
| Title | Proportion of Participants With a Gain ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline |
|---|---|
| Description | The summary by visit was conducted based on the BCVA observed from each of the corresponding visits. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart. |
| Time Frame | Baseline and every 4 weeks from baseline up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4; BCVA gain from baseline >=5 |
154
68.1%
|
150
67%
|
| Week 4; BCVA gain from baseline >=10 |
102
45.1%
|
110
49.1%
|
| Week 4; BCVA gain from baseline >=15 |
64
28.3%
|
79
35.3%
|
| Week 8; BCVA gain from baseline >=5 |
158
69.9%
|
155
69.2%
|
| Week 8; BCVA gain from baseline >=10 |
117
51.8%
|
118
52.7%
|
| Week 8; BCVA gain from baseline >=15 |
92
40.7%
|
93
41.5%
|
| Week 12; BCVA gain from baseline >=5 |
156
69%
|
156
69.6%
|
| Week 12; BCVA gain from baseline >=10 |
114
50.4%
|
125
55.8%
|
| Week 12; BCVA gain from baseline >=15 |
90
39.8%
|
102
45.5%
|
| Week 16; BCVA gain from baseline >=5 |
127
56.2%
|
143
63.8%
|
| Week 16; BCVA gain from baseline >=10 |
95
42%
|
118
52.7%
|
| Week 16; BCVA gain from baseline >=15 |
73
32.3%
|
100
44.6%
|
| Week 20; BCVA gain from baseline >=5 |
119
52.7%
|
131
58.5%
|
| Week 20; BCVA gain from baseline >=10 |
96
42.5%
|
108
48.2%
|
| Week 20; BCVA gain from baseline >=15 |
74
32.7%
|
92
41.1%
|
| Week 24; BCVA gain from baseline >=5 |
122
54%
|
126
56.3%
|
| Week 24; BCVA gain from baseline >=10 |
90
39.8%
|
109
48.7%
|
| Week 24; BCVA gain from baseline >=15 |
75
33.2%
|
91
40.6%
|
| Week 28; BCVA gain from baseline >=5 |
108
47.8%
|
121
54%
|
| Week 28; BCVA gain from baseline >=10 |
89
39.4%
|
107
47.8%
|
| Week 28; BCVA gain from baseline >=15 |
75
33.2%
|
87
38.8%
|
| Week 32; BCVA gain from baseline >=5 |
97
42.9%
|
110
49.1%
|
| Week 32; BCVA gain from baseline >=10 |
79
35%
|
94
42%
|
| Week 32; BCVA gain from baseline >=15 |
60
26.5%
|
78
34.8%
|
| Week 36; BCVA gain from baseline >=5 |
100
44.2%
|
112
50%
|
| Week 36; BCVA gain from baseline >=10 |
81
35.8%
|
98
43.8%
|
| Week 36; BCVA gain from baseline >=15 |
62
27.4%
|
83
37.1%
|
| Week 40; BCVA gain from baseline >=5 |
96
42.5%
|
114
50.9%
|
| Week 40; BCVA gain from baseline >=10 |
79
35%
|
98
43.8%
|
| Week 40; BCVA gain from baseline >=15 |
65
28.8%
|
85
37.9%
|
| Week 44; BCVA gain from baseline >=5 |
94
41.6%
|
111
49.6%
|
| Week 44; BCVA gain from baseline >=10 |
78
34.5%
|
97
43.3%
|
| Week 44; BCVA gain from baseline >=15 |
64
28.3%
|
88
39.3%
|
| Week 48; BCVA gain from baseline >=5 |
92
40.7%
|
112
50%
|
| Week 48; BCVA gain from baseline >=10 |
76
33.6%
|
95
42.4%
|
| Week 48; BCVA gain from baseline >=15 |
61
27%
|
80
35.7%
|
| Week 52; BCVA gain from baseline >=5 |
87
38.5%
|
117
52.2%
|
| Week 52; BCVA gain from baseline >=10 |
75
33.2%
|
99
44.2%
|
| Week 52; BCVA gain from baseline >=15 |
64
28.3%
|
87
38.8%
|
| Week 56; BCVA gain from baseline >=5 |
90
39.8%
|
113
50.4%
|
| Week 56; BCVA gain from baseline >=10 |
76
33.6%
|
106
47.3%
|
| Week 56; BCVA gain from baseline >=15 |
58
25.7%
|
84
37.5%
|
| Week 60; BCVA gain from baseline >=5 |
86
38.1%
|
116
51.8%
|
| Week 60; BCVA gain from baseline >=10 |
71
31.4%
|
104
46.4%
|
| Week 60; BCVA gain from baseline >=15 |
62
27.4%
|
88
39.3%
|
| Week 64; BCVA gain from baseline >=5 |
86
38.1%
|
112
50%
|
| Week 64; BCVA gain from baseline >=10 |
74
32.7%
|
98
43.8%
|
| Week 64; BCVA gain from baseline >=15 |
58
25.7%
|
82
36.6%
|
| Week 68; BCVA gain from baseline >=5 |
79
35%
|
103
46%
|
| Week 68; BCVA gain from baseline >=10 |
67
29.6%
|
88
39.3%
|
| Week 68; BCVA gain from baseline >=15 |
55
24.3%
|
76
33.9%
|
| Week 72; BCVA gain from baseline >=5 |
68
30.1%
|
89
39.7%
|
| Week 72; BCVA gain from baseline >=10 |
56
24.8%
|
75
33.5%
|
| Week 72; BCVA gain from baseline >=15 |
45
19.9%
|
63
28.1%
|
| Week 76; BCVA gain from baseline >=5 |
62
27.4%
|
67
29.9%
|
| Week 76; BCVA gain from baseline >=10 |
52
23%
|
61
27.2%
|
| Week 76; BCVA gain from baseline >=15 |
43
19%
|
53
23.7%
|
| Title | Proportion of Participants With a Loss ≥ 5, 10 and 15 Letters in BCVA by Visit Compared to Baseline |
|---|---|
| Description | The summary by visit was conducted based on the BCVA observed from each of the corresponding visit. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters. Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning. Every 5 letters represents 1 line of vision on the reading chart. |
| Time Frame | Baseline and every 4 weeks from baseline up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had a valid assessment for both baseline and the corresponding post baseline visit. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4; BCVA loss from baseline >=5 |
6
2.7%
|
7
3.1%
|
| Week 4; BCVA loss from baseline >=10 |
1
0.4%
|
3
1.3%
|
| Week 4; BCVA loss from baseline >=15 |
0
0%
|
0
0%
|
| Week 8; BCVA loss from baseline >=5 |
2
0.9%
|
4
1.8%
|
| Week 8; BCVA loss from baseline >=10 |
1
0.4%
|
2
0.9%
|
| Week 8; BCVA loss from baseline >=15 |
1
0.4%
|
0
0%
|
| Week 12; BCVA loss from baseline >=5 |
3
1.3%
|
2
0.9%
|
| Week 12; BCVA loss from baseline >=10 |
2
0.9%
|
1
0.4%
|
| Week 12; BCVA loss from baseline >=15 |
1
0.4%
|
0
0%
|
| Week 16; BCVA loss from baseline >=5 |
9
4%
|
4
1.8%
|
| Week 16; BCVA loss from baseline >=10 |
5
2.2%
|
2
0.9%
|
| Week 16; BCVA loss from baseline >=15 |
3
1.3%
|
2
0.9%
|
| Week 20; BCVA loss from baseline >=5 |
6
2.7%
|
4
1.8%
|
| Week 20; BCVA loss from baseline >=10 |
2
0.9%
|
3
1.3%
|
| Week 20; BCVA loss from baseline >=15 |
2
0.9%
|
1
0.4%
|
| Week 24; BCVA loss from baseline >=5 |
8
3.5%
|
3
1.3%
|
| Week 24; BCVA loss from baseline >=10 |
3
1.3%
|
3
1.3%
|
| Week 24; BCVA loss from baseline >=15 |
3
1.3%
|
1
0.4%
|
| Week 28; BCVA loss from baseline >=5 |
9
4%
|
2
0.9%
|
| Week 28; BCVA loss from baseline >=10 |
6
2.7%
|
1
0.4%
|
| Week 28; BCVA loss from baseline >=15 |
6
2.7%
|
1
0.4%
|
| Week 32; BCVA loss from baseline >=5 |
8
3.5%
|
3
1.3%
|
| Week 32; BCVA loss from baseline >=10 |
5
2.2%
|
2
0.9%
|
| Week 32; BCVA loss from baseline >=15 |
3
1.3%
|
0
0%
|
| Week 36; BCVA loss from baseline >=5 |
9
4%
|
2
0.9%
|
| Week 36; BCVA loss from baseline >=10 |
7
3.1%
|
1
0.4%
|
| Week 36; BCVA loss from baseline >=15 |
5
2.2%
|
1
0.4%
|
| Week 40; BCVA loss from baseline >=5 |
5
2.2%
|
4
1.8%
|
| Week 40; BCVA loss from baseline >=10 |
4
1.8%
|
1
0.4%
|
| Week 40; BCVA loss from baseline >=15 |
2
0.9%
|
1
0.4%
|
| Week 44; BCVA loss from baseline >=5 |
4
1.8%
|
5
2.2%
|
| Week 44; BCVA loss from baseline >=10 |
3
1.3%
|
3
1.3%
|
| Week 44; BCVA loss from baseline >=15 |
2
0.9%
|
2
0.9%
|
| Week 48; BCVA loss from baseline >=5 |
5
2.2%
|
3
1.3%
|
| Week 48; BCVA loss from baseline >=10 |
3
1.3%
|
1
0.4%
|
| Week 48; BCVA loss from baseline >=15 |
1
0.4%
|
1
0.4%
|
| Week 52; BCVA loss from baseline >=5 |
5
2.2%
|
2
0.9%
|
| Week 52; BCVA loss from baseline >=10 |
3
1.3%
|
1
0.4%
|
| Week 52; BCVA loss from baseline >=15 |
2
0.9%
|
1
0.4%
|
| Week 56; BCVA loss from baseline >=5 |
3
1.3%
|
3
1.3%
|
| Week 56; BCVA loss from baseline >=10 |
1
0.4%
|
1
0.4%
|
| Week 56; BCVA loss from baseline >=15 |
0
0%
|
0
0%
|
| Week 60; BCVA loss from baseline >=5 |
7
3.1%
|
2
0.9%
|
| Week 60; BCVA loss from baseline >=10 |
3
1.3%
|
0
0%
|
| Week 60; BCVA loss from baseline >=15 |
1
0.4%
|
0
0%
|
| Week 64; BCVA loss from baseline >=5 |
5
2.2%
|
2
0.9%
|
| Week 64; BCVA loss from baseline >=10 |
1
0.4%
|
1
0.4%
|
| Week 64; BCVA loss from baseline >=15 |
1
0.4%
|
1
0.4%
|
| Week 68; BCVA loss from baseline >=5 |
6
2.7%
|
3
1.3%
|
| Week 68; BCVA loss from baseline >=10 |
3
1.3%
|
1
0.4%
|
| Week 68; BCVA loss from baseline >=15 |
1
0.4%
|
0
0%
|
| Week 72; BCVA loss from baseline >=5 |
1
0.4%
|
2
0.9%
|
| Week 72; BCVA loss from baseline >=10 |
1
0.4%
|
2
0.9%
|
| Week 72; BCVA loss from baseline >=15 |
1
0.4%
|
1
0.4%
|
| Week 76; BCVA loss from baseline >=5 |
2
0.9%
|
2
0.9%
|
| Week 76; BCVA loss from baseline >=10 |
1
0.4%
|
0
0%
|
| Week 76; BCVA loss from baseline >=15 |
1
0.4%
|
0
0%
|
| Title | Change From Baseline in CSFT Averaged Over Week 40 to Week 52 |
|---|---|
| Description | Change from baseline in central subfield thickness (CSFT) averaged over Week 40 to Week 52 , measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Time Frame | Baseline, Week 40 to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 123 | 132 |
| Mean (Standard Deviation) [µm] |
-231.8
(188.97)
|
-259.2
(190.69)
|
| Title | Change From Baseline in CSFT Averaged Over Week 64 to Week 76 |
|---|---|
| Description | Change from baseline in central subfield thickness (CSFT) averaged over Week 64 to Week 76, measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Time Frame | Baseline, Week 64 to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had at least one CSFT assessment on scheduled visits over the corresponding time point |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 110 | 121 |
| Mean (Standard Deviation) [µm] |
-243.6
(201.61)
|
-272.6
(194.29)
|
| Title | Change From Baseline in CSFT by Visit up to Week 76 |
|---|---|
| Description | Change from baseline in central subfield thickness (CSFT) measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Time Frame | Baseline, and every 4 weeks from baseline up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had CSFT data available on baseline and the specific post-baseline visit. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4 |
-247.1
(197.99)
|
-259.4
(185.11)
|
| Week 8 |
-255.9
(206.00)
|
-270.7
(195.49)
|
| Week 12 |
-264.5
(208.70)
|
-271.9
(194.99)
|
| Week 16 |
-271.1
(209.38)
|
-276.1
(209.70)
|
| Week 20 |
-257.1
(197.31)
|
-285.2
(210.32)
|
| Week 24 |
-254.9
(203.29)
|
-286.6
(207.67)
|
| Week 28 |
-245.4
(197.62)
|
-263.6
(197.11)
|
| Week 32 |
-231.1
(208.02)
|
-262.1
(193.80)
|
| Week 36 |
-234.1
(199.02)
|
-260.8
(195.03)
|
| Week 40 |
-224.7
(190.50)
|
-259.0
(189.01)
|
| Week 44 |
-242.8
(197.34)
|
-264.1
(192.06)
|
| Week 48 |
-237.1
(200.64)
|
-279.4
(193.41)
|
| Week 52 |
-243.0
(203.87)
|
-263.4
(190.36)
|
| Week 56 |
-249.2
(206.54)
|
-271.4
(198.09)
|
| Week 60 |
-238.3
(185.78)
|
-265.3
(187.29)
|
| Week 64 |
-249.8
(207.86)
|
-266.1
(199.79)
|
| Week 68 |
-247.5
(217.61)
|
-261.1
(192.30)
|
| Week 72 |
-253.4
(211.06)
|
-279.4
(185.21)
|
| Week 76 |
-255.6
(184.22)
|
-283.7
(197.29)
|
| Title | Proportion of Subjects With Presence of Retinal Fluid (Intra- and/or Subretinal Fluid) in the Study Eye by Visit up to Week 76 |
|---|---|
| Description | Presence of retinal fluid (intra- and/or subretinal fluid) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Time Frame | Every 4 weeks from baseline up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had data at each time point |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4 |
83
36.7%
|
101
45.1%
|
| Week 8 |
56
24.8%
|
68
30.4%
|
| Week 12 |
41
18.1%
|
49
21.9%
|
| Week 16 |
34
15%
|
50
22.3%
|
| Week 20 |
33
14.6%
|
45
20.1%
|
| Week 24 |
35
15.5%
|
42
18.8%
|
| Week 28 |
47
20.8%
|
56
25%
|
| Week 32 |
58
25.7%
|
50
22.3%
|
| Week 36 |
48
21.2%
|
57
25.4%
|
| Week 40 |
42
18.6%
|
56
25%
|
| Week 44 |
43
19%
|
54
24.1%
|
| Week 48 |
44
19.5%
|
49
21.9%
|
| Week 52 |
34
15%
|
57
25.4%
|
| Week 56 |
34
15%
|
54
24.1%
|
| Week 60 |
39
17.3%
|
63
28.1%
|
| Week 64 |
31
13.7%
|
52
23.2%
|
| Week 68 |
34
15%
|
52
23.2%
|
| Week 72 |
33
14.6%
|
39
17.4%
|
| Week 76 |
16
7.1%
|
38
17%
|
| Title | Proportion of Subjects With a CSFT < 300 µm for the Study Eye by Visit up to Week 76 |
|---|---|
| Description | Central subfield thickness (CSFT) is measured in µm by Spectral Domain Optical Coherence Tomography (SD-OCT) |
| Time Frame | Every 4 weeks from Week 4 up to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had non-missing CSFT assessment at the corresponding visit |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 4 |
167
73.9%
|
153
68.3%
|
| Week 8 |
172
76.1%
|
166
74.1%
|
| Week 12 |
156
69%
|
155
69.2%
|
| Week 16 |
137
60.6%
|
131
58.5%
|
| Week 20 |
120
53.1%
|
118
52.7%
|
| Week 24 |
127
56.2%
|
114
50.9%
|
| Week 28 |
109
48.2%
|
103
46%
|
| Week 32 |
92
40.7%
|
97
43.3%
|
| Week 36 |
96
42.5%
|
91
40.6%
|
| Week 40 |
94
41.6%
|
92
41.1%
|
| Week 44 |
95
42%
|
93
41.5%
|
| Week 48 |
89
39.4%
|
97
43.3%
|
| Week 52 |
86
38.1%
|
95
42.4%
|
| Week 56 |
86
38.1%
|
91
40.6%
|
| Week 60 |
83
36.7%
|
90
40.2%
|
| Week 64 |
85
37.6%
|
90
40.2%
|
| Week 68 |
82
36.3%
|
79
35.3%
|
| Week 72 |
70
31%
|
76
33.9%
|
| Week 76 |
59
26.1%
|
59
26.3%
|
| Title | Number of Injections Between Week 24 and Week 52 and Between Week 24 and Week 72 |
|---|---|
| Description | Number of administered injections during the individualized flexible treatment (IFT) period, between Week 24 and Week 52 and between Week 24 and Week 72 are presented |
| Time Frame | Week 24 to Week 52 and Week 24 to Week 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who were on study treatment until week 52 and until week 72. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 111 | 126 |
| Between Week 24 and Week 52 |
2.2
(1.69)
|
2.5
(2.17)
|
| Between Week 24 and Week 72 |
3.2
(2.54)
|
4.0
(3.28)
|
| Title | Time to Recurrence After Week 20 and up to Week 76 |
|---|---|
| Description | Recurrence is defined as the need for injection while showing a lack of disease stability for the first time after Week 20 and up to Week 76. For subjects with recurrence after the Week 20 visit, time-to-event is calculated as (first time with the lack of disease stability - the injection date on Week 20 visit + 1). For subjects without recurrence after Week 20, the censoring time will be calculated as (last visit with disease stability assessment - the injection date on Week 20 visit + 1). |
| Time Frame | Week 20 to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed is the number of subjects from the FAS who did not discontinue from study treatment on or before Week 20. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 157 | 159 |
| Median (95% Confidence Interval) [Weeks] |
12.9
|
13.1
|
| Title | Number of Subjects With Ocular and Non-ocular AEs up to Week 52 and Week 76 |
|---|---|
| Description | Number of subjects with at least one ocular or non-ocular Adverse Events (AEs). |
| Time Frame | Baseline to Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Ocular AEs up to week 52 |
93
41.2%
|
72
32.1%
|
| Non-Ocular AEs up to week 52 |
94
41.6%
|
112
50%
|
| Ocular AEs up to week 76 |
98
43.4%
|
75
33.5%
|
| Non-Ocular AEs up to week 76 |
103
45.6%
|
120
53.6%
|
| Title | Change From Baseline in Patient Reported Outcomes (NEI VFQ-25) at Week 24, Week 52 and Week 76 |
|---|---|
| Description | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures a patient's subjective assessment of vision-related Quality of Life (QoL). The 11 subscales in the VFQ-25 are general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated better vision-related quality of life. |
| Time Frame | Baseline, Week 24, Week 52 and Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS-observed: The overall number of participants analyzed is the Full Analysis Set (FAS) that included all randomized subjects who received at least one intravitreal injection of the study treatment. The number analyzed per row is the number of subjects from the FAS who had NEI VFQ-25 assessment on scheduled visits. |
| Arm/Group Title | Brolucizumab 6 mg | Aflibercept 2 mg |
|---|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 | 224 |
| Week 24 |
5.6
(11.51)
|
6.4
(11.92)
|
| Week 52 |
6.9
(13.21)
|
7.6
(10.47)
|
| Week 76 |
8.6
(13.89)
|
7.5
(11.55)
|
| Title | Number of Subjects According to Their Anti-drug Antibody (ADA) Titer at Screening and Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 |
|---|---|
| Description | Anti-drug antibodies (ADA) levels were assessed from subjects assigned to brolucizumab treatment only. |
| Time Frame | Baseline, Week 4, Week 12, Week 24, Week 36, Week 52 and Week 76 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SAF-observed: Safety Analysis Set (SAF) included all subjects who received at least one intravitreal injection with brolucizumab. The number analyzed is the number of subjects from the SAF who had a value for ADA status on scheduled visits. |
| Arm/Group Title | Brolucizumab 6 mg |
|---|---|
| Arm/Group Description | 1 intravitreal injection every 4 weeks for a total of 6 injections, followed by 48 weeks of individualized flexible treatment (IFT) |
| Measure Participants | 226 |
| Negative |
67
29.6%
|
| 40 |
29
12.8%
|
| 120 |
33
14.6%
|
| 360 |
37
16.4%
|
| 1080 |
31
13.7%
|
| 3240 |
15
6.6%
|
| 9720 |
1
0.4%
|
| 29200 |
6
2.7%
|
| Negative |
76
33.6%
|
| 40 |
29
12.8%
|
| 120 |
31
13.7%
|
| 360 |
28
12.4%
|
| 1080 |
27
11.9%
|
| 3240 |
9
4%
|
| 9720 |
6
2.7%
|
| 29200 |
2
0.9%
|
| Negative |
58
25.7%
|
| 40 |
17
7.5%
|
| 120 |
31
13.7%
|
| 360 |
25
11.1%
|
| 1080 |
19
8.4%
|
| 3240 |
11
4.9%
|
| 9720 |
7
3.1%
|
| 29200 |
2
0.9%
|
| Negative |
44
19.5%
|
| 40 |
14
6.2%
|
| 120 |
23
10.2%
|
| 360 |
17
7.5%
|
| 1080 |
19
8.4%
|
| 3240 |
11
4.9%
|
| 9720 |
5
2.2%
|
| 29200 |
1
0.4%
|
| Negative |
33
14.6%
|
| 40 |
18
8%
|
| 120 |
19
8.4%
|
| 360 |
17
7.5%
|
| 1080 |
17
7.5%
|
| 3240 |
8
3.5%
|
| 9720 |
1
0.4%
|
| 29200 |
1
0.4%
|
| Negative |
28
12.4%
|
| 40 |
18
8%
|
| 120 |
19
8.4%
|
| 360 |
16
7.1%
|
| 1080 |
14
6.2%
|
| 3240 |
5
2.2%
|
| 9720 |
1
0.4%
|
| 29200 |
0
0%
|
| Negative |
17
7.5%
|
| 40 |
6
2.7%
|
| 120 |
18
8%
|
| 360 |
14
6.2%
|
| 1080 |
10
4.4%
|
| 3240 |
2
0.9%
|
| 9720 |
1
0.4%
|
| 29200 |
0
0%
|
Adverse Events
| Time Frame | Adverse events were collected from first dose of study treatment until end of study treatment plus 4 weeks post treatment, up to maximum duration of 76 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Any sign or symptom that occurs during the study treatment plus the 4 weeks post treatment | |||||
| Arm/Group Title | Brolucizumab 6mg | Aflibercept 2mg | Overall | |||
| Arm/Group Description | Brolucizumab 6mg | Aflibercept 2mg | Overall | |||
All Cause Mortality |
||||||
| Brolucizumab 6mg | Aflibercept 2mg | Overall | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/226 (0%) | 2/224 (0.9%) | 2/450 (0.4%) | |||
Serious Adverse Events |
||||||
| Brolucizumab 6mg | Aflibercept 2mg | Overall | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/226 (14.2%) | 16/224 (7.1%) | 48/450 (10.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cardiac disorders | ||||||
| Angina pectoris | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Atrial fibrillation | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cardiac arrest | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cardiac failure | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cardiac failure congestive | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cardiac valve disease | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Myocardial infarction | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Palpitations | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Congenital, familial and genetic disorders | ||||||
| Atrial septal defect | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Eye disorders | ||||||
| Cataract - Fellow eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Cataract - Study eye | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Glaucoma - Fellow eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Glaucoma - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Iridocyclitis - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Retinal aneurysm - Study eye | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Retinal artery occlusion - Fellow eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Retinal artery occlusion - Study eye | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Retinal detachment - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Retinal occlusive vasculitis - Study eye | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Retinal vascular occlusion - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Retinal vasculitis - Study eye | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Uveitis - Study eye | 3/226 (1.3%) | 0/224 (0%) | 3/450 (0.7%) | |||
| Vitreous haemorrhage - Study eye | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Vitreous opacities - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Vitritis - Study eye | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Gastrointestinal disorders | ||||||
| Mallory-Weiss syndrome | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Pancreatitis acute | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| General disorders | ||||||
| Chest pain | 1/226 (0.4%) | 1/224 (0.4%) | 2/450 (0.4%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis acute | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Infections and infestations | ||||||
| Bronchitis | 1/226 (0.4%) | 1/224 (0.4%) | 2/450 (0.4%) | |||
| COVID-19 | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| COVID-19 pneumonia | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Endophthalmitis - Study eye | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Injury, poisoning and procedural complications | ||||||
| Dislocation of vertebra | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Fall | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Subdural haemorrhage | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Investigations | ||||||
| Weight increased | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Muscular weakness | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Osteoarthritis | 1/226 (0.4%) | 1/224 (0.4%) | 2/450 (0.4%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Bladder neoplasm | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Eyelid seborrhoeic keratosis - Fellow eye | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Prostate cancer | 2/226 (0.9%) | 0/224 (0%) | 2/450 (0.4%) | |||
| Nervous system disorders | ||||||
| Cerebral infarction | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Cerebrovascular accident | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Ischaemic stroke | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Syncope | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Transient ischaemic attack | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Product Issues | ||||||
| Device dislocation | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Psychiatric disorders | ||||||
| Depression | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Renal and urinary disorders | ||||||
| Urinary retention | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pleural mass | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
| Vascular disorders | ||||||
| Aortic stenosis | 1/226 (0.4%) | 0/224 (0%) | 1/450 (0.2%) | |||
| Vasospasm | 0/226 (0%) | 1/224 (0.4%) | 1/450 (0.2%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Brolucizumab 6mg | Aflibercept 2mg | Overall | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 109/226 (48.2%) | 95/224 (42.4%) | 204/450 (45.3%) | |||
| Eye disorders | ||||||
| Cataract - Study eye | 9/226 (4%) | 2/224 (0.9%) | 11/450 (2.4%) | |||
| Conjunctival haemorrhage - Study eye | 11/226 (4.9%) | 12/224 (5.4%) | 23/450 (5.1%) | |||
| Dry eye - Fellow eye | 5/226 (2.2%) | 9/224 (4%) | 14/450 (3.1%) | |||
| Dry eye - Study eye | 6/226 (2.7%) | 9/224 (4%) | 15/450 (3.3%) | |||
| Eye pain - Study eye | 4/226 (1.8%) | 11/224 (4.9%) | 15/450 (3.3%) | |||
| Foreign body sensation in eyes - Study eye | 5/226 (2.2%) | 1/224 (0.4%) | 6/450 (1.3%) | |||
| Macular oedema - Study eye | 15/226 (6.6%) | 10/224 (4.5%) | 25/450 (5.6%) | |||
| Retinal exudates - Study eye | 5/226 (2.2%) | 8/224 (3.6%) | 13/450 (2.9%) | |||
| Retinal haemorrhage - Study eye | 2/226 (0.9%) | 8/224 (3.6%) | 10/450 (2.2%) | |||
| Uveitis - Study eye | 5/226 (2.2%) | 0/224 (0%) | 5/450 (1.1%) | |||
| Visual acuity reduced - Study eye | 15/226 (6.6%) | 12/224 (5.4%) | 27/450 (6%) | |||
| Vitreous detachment - Study eye | 5/226 (2.2%) | 5/224 (2.2%) | 10/450 (2.2%) | |||
| Vitreous floaters - Study eye | 11/226 (4.9%) | 5/224 (2.2%) | 16/450 (3.6%) | |||
| Vitreous opacities - Study eye | 5/226 (2.2%) | 1/224 (0.4%) | 6/450 (1.3%) | |||
| Vitritis - Study eye | 5/226 (2.2%) | 0/224 (0%) | 5/450 (1.1%) | |||
| Gastrointestinal disorders | ||||||
| Toothache | 5/226 (2.2%) | 3/224 (1.3%) | 8/450 (1.8%) | |||
| Infections and infestations | ||||||
| COVID-19 | 7/226 (3.1%) | 7/224 (3.1%) | 14/450 (3.1%) | |||
| Nasopharyngitis | 6/226 (2.7%) | 7/224 (3.1%) | 13/450 (2.9%) | |||
| Upper respiratory tract infection | 2/226 (0.9%) | 7/224 (3.1%) | 9/450 (2%) | |||
| Urinary tract infection | 5/226 (2.2%) | 6/224 (2.7%) | 11/450 (2.4%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall | 3/226 (1.3%) | 5/224 (2.2%) | 8/450 (1.8%) | |||
| Investigations | ||||||
| Intraocular pressure increased - Fellow eye | 3/226 (1.3%) | 6/224 (2.7%) | 9/450 (2%) | |||
| Intraocular pressure increased - Study eye | 4/226 (1.8%) | 8/224 (3.6%) | 12/450 (2.7%) | |||
| Metabolism and nutrition disorders | ||||||
| Hypercholesterolaemia | 5/226 (2.2%) | 3/224 (1.3%) | 8/450 (1.8%) | |||
| Type 2 diabetes mellitus | 5/226 (2.2%) | 0/224 (0%) | 5/450 (1.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 2/226 (0.9%) | 6/224 (2.7%) | 8/450 (1.8%) | |||
| Back pain | 2/226 (0.9%) | 7/224 (3.1%) | 9/450 (2%) | |||
| Osteoarthritis | 6/226 (2.7%) | 2/224 (0.9%) | 8/450 (1.8%) | |||
| Nervous system disorders | ||||||
| Dizziness | 4/226 (1.8%) | 7/224 (3.1%) | 11/450 (2.4%) | |||
| Vascular disorders | ||||||
| Hypertension | 26/226 (11.5%) | 19/224 (8.5%) | 45/450 (10%) | |||
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 | 862-778-8300 |
| novartis.email@novartis.com |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03802630
Other Study ID Numbers:
- CRTH258C2301
- 2018-001842-33
First Posted:
Jan 14, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jun 1, 2022