Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, intravitreal injection, brolucizumab, aflibercept, double-masked, Diabetic Macular Edema (DME), macular edema, diabetic retinopathy
Brief summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Detailed description
This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100. Subjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase. Disease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.
Interventions
DRUGBrolucizumab
Intravitreal injection
DRUGAflibercept
Intravitreal injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent before any assessment * Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening * Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion criteria
* Active proliferative diabetic retinopathy in the study eye * Active intraocular or periocular infection or active intraocular inflammation in study eye * Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg) * Previous treatment with anti-VEGF drugs or investigational drugs in the study eye * Stroke or myocardial infarction during the 6-month period prior to baseline * Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | Baseline, Week 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Maintained at q12w - Probability of Maintaining on q12w | Baseline (Week 0), Weeks 32, 36 and 48 | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only. |
| Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Weeks 36 and 48 | Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 8 weeks (q8w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only. |
| Change From Baseline in BCVA at Each Visit up to Week 52 | Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. |
| BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | Baseline, and Week 88 through Week 100 (average) | Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. |
| Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 | This outcome measure is pre-specified for brolucizumab treatment arms only |
| Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96 | This outcome measure is pre-specified for brolucizumab treatment arms only |
| Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | Baseline up to week 52 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. |
| Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | Baseline, and Week 88 through Week 100 (average) | Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. |
| Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Baseline up to Week 52 and Week 100 | Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit |
| Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Baseline, up to Week 52 and Week 100 | Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit |
| Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Baseline, up to Week 52 and Week 100 | Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit |
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | Week 52 | Assessed by angiography. |
| Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | Week 100 | Assessed by angiography. |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Baseline, Weeks 28, 52, 76, 100 | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Baseline, Weeks 28, 52, 76, 100 | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a \>=2-step Improvement From Baseline in the DRSS Score from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E. |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Baseline, Weeks 28, 52, 76, 100 | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. |
| Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | Baseline and Week 40 through Week 52 (average) | BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Baseline, Weeks 28, 52, 76, 100 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales. |
| Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. | — |
| Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks. | — |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Baseline, Weeks 28, 52, 76, 100 | Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a \>=3-step Improvement From Baseline in the DRSS Score from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E. |
Countries
Argentina, Australia, Austria, Canada, Colombia, Israel, Italy, Japan, Netherlands, Portugal, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 3 mg Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | 190 |
| Brolucizumab 6 mg Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule | 189 |
| Aflibercept 2 mg Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks | 187 |
| Total | 566 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 | 7 |
| Overall Study | Death | 4 | 8 | 7 |
| Overall Study | Lost to Follow-up | 3 | 4 | 4 |
| Overall Study | Physician Decision | 3 | 0 | 1 |
| Overall Study | Progressive disease | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 16 | 19 | 14 |
Baseline characteristics
| Characteristic | Brolucizumab 3 mg | Brolucizumab 6 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 93 Participants | 85 Participants | 94 Participants | 272 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 104 Participants | 93 Participants | 294 Participants |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 9.76 | 62.4 years STANDARD_DEVIATION 10.14 | 63.9 years STANDARD_DEVIATION 10.09 | 63.6 years STANDARD_DEVIATION 10.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 25 Participants | 26 Participants | 76 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 4 Participants | 7 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 151 Participants | 158 Participants | 152 Participants | 461 Participants |
| Sex: Female, Male Female | 71 Participants | 79 Participants | 61 Participants | 211 Participants |
| Sex: Female, Male Male | 119 Participants | 110 Participants | 126 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 190 | 8 / 189 | 7 / 187 | 19 / 566 |
| other Total, other adverse events | 146 / 190 | 148 / 189 | 137 / 187 | 431 / 566 |
| serious Total, serious adverse events | 58 / 190 | 59 / 189 | 63 / 187 | 180 / 566 |
Outcome results
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Time frame: Baseline, Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF).~This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 7.3 Scores on a scale | Standard Error 0.66 |
| Brolucizumab 6 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | 9.2 Scores on a scale | Standard Error 0.57 |
| Aflibercept 2 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 10.6 Scores on a scale | Standard Error 0.67 |
| Aflibercept 2 mg | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 | LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | 10.5 Scores on a scale | Standard Error 0.57 |
p-value: <0.00195% CI: [-2.9, 0.3]ANOVA
p-value: 0.22795% CI: [-5.1, -1.4]ANOVA
Secondary
Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Time frame: Baseline and Week 40 through Week 52 (average)
Population: Full analysis set (FAS) - Observed.~This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 7.0 Scores on a scale | Standard Error 0.63 |
| Brolucizumab 6 mg | Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | 9.0 Scores on a scale | Standard Error 0.53 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg) | 10.5 Scores on a scale | Standard Error 0.64 |
| Aflibercept 2 mg | Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52 | LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg) | 10.5 Scores on a scale | Standard Error 0.53 |
p-value: <0.00195% CI: [-3, 0]ANOVA
95% CI: [-5.2, -1.7]ANOVA
Secondary
BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)
Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline, and Week 88 through Week 100 (average)
Population: Full Analysis Set - LOCF
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | 6.7 BCVA letters read | Standard Error 0.77 |
| Brolucizumab 6 mg | BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | 8.6 BCVA letters read | Standard Error 0.72 |
| Aflibercept 2 mg | BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | 10.6 BCVA letters read | Standard Error 0.78 |
| Aflibercept 2 mg | BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF) | LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | 10.6 BCVA letters read | Standard Error 0.73 |
95% CI: [-6, -1.7]ANOVA
95% CI: [-4, 0.1]ANOVA
Secondary
Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)
Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline, and Week 88 through Week 100 (average)
Population: Full Analysis Set - LOCF
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | -167.1 micrometers | Standard Error 6.54 |
| Brolucizumab 6 mg | Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | -171.9 micrometers | Standard Error 6.18 |
| Aflibercept 2 mg | Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187) | -168.8 micrometers | Standard Error 6.59 |
| Aflibercept 2 mg | Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF) | LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187) | -168.5 micrometers | Standard Error 6.22 |
95% CI: [-16.6, 20]ANOVA
95% CI: [-20.7, 13.8]ANOVA
Secondary
Change From Baseline in BCVA at Each Visit up to Week 52
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Time frame: Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Full analysis set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 18 (n=175,181,172) | 7.6 Scores on a scale | Standard Deviation 6.35 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 8 (n=183,184,181) | 5.6 Scores on a scale | Standard Deviation 5.9 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 36 (n=154,166,165) | 6.9 Scores on a scale | Standard Deviation 8.1 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 20 (n=176,177,176) | 7.8 Scores on a scale | Standard Deviation 7.59 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 6 (n=185,186,180) | 5.1 Scores on a scale | Standard Deviation 5.86 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 32 (n=155,161,162) | 8.2 Scores on a scale | Standard Deviation 7.76 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 24 (n=174,178,177) | 8.1 Scores on a scale | Standard Deviation 6.42 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 44 (n=156,157,163) | 7.5 Scores on a scale | Standard Deviation 10.92 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 28 (n=170,175,170) | 8.2 Scores on a scale | Standard Deviation 6.58 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 12 (n=183,186,182) | 6.7 Scores on a scale | Standard Deviation 5.93 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 52 (n=156,153,160) | 7.8 Scores on a scale | Standard Deviation 10.72 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 4 (n=187, 186, 185) | 4.0 Scores on a scale | Standard Deviation 5.02 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 16 (n=173,179,179) | 7.0 Scores on a scale | Standard Deviation 7 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 48 (n=155,154,159) | 7.2 Scores on a scale | Standard Deviation 11.53 |
| Brolucizumab 3 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 40 (n=160,163,163) | 7.3 Scores on a scale | Standard Deviation 10.47 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 40 (n=160,163,163) | 9.5 Scores on a scale | Standard Deviation 7.99 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 4 (n=187, 186, 185) | 4.5 Scores on a scale | Standard Deviation 5.22 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 6 (n=185,186,180) | 6.0 Scores on a scale | Standard Deviation 6.22 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 8 (n=183,184,181) | 6.6 Scores on a scale | Standard Deviation 6.54 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 12 (n=183,186,182) | 7.3 Scores on a scale | Standard Deviation 6.57 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 16 (n=173,179,179) | 7.5 Scores on a scale | Standard Deviation 6.83 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 18 (n=175,181,172) | 8.0 Scores on a scale | Standard Deviation 6.84 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 20 (n=176,177,176) | 8.3 Scores on a scale | Standard Deviation 7.51 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 24 (n=174,178,177) | 9.3 Scores on a scale | Standard Deviation 7.08 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 28 (n=170,175,170) | 9.6 Scores on a scale | Standard Deviation 7.4 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 32 (n=155,161,162) | 9.2 Scores on a scale | Standard Deviation 7.2 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 36 (n=154,166,165) | 8.6 Scores on a scale | Standard Deviation 8.15 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 44 (n=156,157,163) | 9.6 Scores on a scale | Standard Deviation 7.66 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 48 (n=155,154,159) | 10.0 Scores on a scale | Standard Deviation 7.63 |
| Brolucizumab 6 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 52 (n=156,153,160) | 10.2 Scores on a scale | Standard Deviation 7.66 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 18 (n=175,181,172) | 8.8 Scores on a scale | Standard Deviation 7.27 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 48 (n=155,154,159) | 11.1 Scores on a scale | Standard Deviation 8.75 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 36 (n=154,166,165) | 10.2 Scores on a scale | Standard Deviation 7.84 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 16 (n=173,179,179) | 8.5 Scores on a scale | Standard Deviation 7.36 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 12 (n=183,186,182) | 8.1 Scores on a scale | Standard Deviation 7.63 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 40 (n=160,163,163) | 10.0 Scores on a scale | Standard Deviation 8.28 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 8 (n=183,184,181) | 7.1 Scores on a scale | Standard Deviation 7.57 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 4 (n=187, 186, 185) | 5.1 Scores on a scale | Standard Deviation 6.74 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 44 (n=156,157,163) | 10.7 Scores on a scale | Standard Deviation 8.25 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 24 (n=174,178,177) | 9.2 Scores on a scale | Standard Deviation 7.84 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 6 (n=185,186,180) | 6.8 Scores on a scale | Standard Deviation 6.8 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 28 (n=170,175,170) | 10.3 Scores on a scale | Standard Deviation 7.26 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 20 (n=176,177,176) | 9.8 Scores on a scale | Standard Deviation 7.47 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 52 (n=156,153,160) | 10.7 Scores on a scale | Standard Deviation 8.87 |
| Aflibercept 2 mg | Change From Baseline in BCVA at Each Visit up to Week 52 | Week 32 (n=155,161,162) | 9.9 Scores on a scale | Standard Deviation 7.89 |
Secondary
Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. LS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.
Time frame: Baseline up to week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 4 (n=190, 0, 187) | -104.7 μm | Standard Error 6.11 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 16 (n=190, 0, 187) | -142.3 μm | Standard Error 5.98 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 28 (n=190, 0, 187) | -163.4 μm | Standard Error 5.81 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 32 (n=190, 0, 187) | -147.4 μm | Standard Error 6.68 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 18 (n=190, 0, 187) | -138.1 μm | Standard Error 6.27 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 36 (n=190, 0, 187) | -119.8 μm | Standard Error 7.74 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 40 (n=190, 0, 187) | -155.8 μm | Standard Error 6.46 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 12 (n=190, 0, 187) | -131.0 μm | Standard Error 6.14 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 20 (n=190, 0, 187) | -151.8 μm | Standard Error 6.01 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 44 (n=190, 0, 187) | -155.4 μm | Standard Error 6.56 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 6 (n=190, 0, 187) | -107.1 μm | Standard Error 6.24 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 48 (n=190, 0, 187) | -144.2 μm | Standard Error 6.92 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 24 (n=190, 0, 187) | -152.6 μm | Standard Error 6.37 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 52 (n=190, 0, 187) | -156.4 μm | Standard Error 6.7 |
| Brolucizumab 3 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 8 (n=190, 0, 187) | -125.1 μm | Standard Error 6.06 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 52 (n=0, 189, 187) | -165.5 μm | Standard Error 6.17 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 40 (n=0, 189, 187) | -156.9 μm | Standard Error 6.68 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 12 (n=0, 189, 187) | -134.5 μm | Standard Error 6.22 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 4 (n=0, 189, 187) | -105.6 μm | Standard Error 5.92 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 28 (n=0, 189, 187) | -163.3 μm | Standard Error 5.97 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 16 (n=0, 189, 187) | -146.5 μm | Standard Error 5.83 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 48 (n=0, 189, 187) | -153.5 μm | Standard Error 6.52 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg)- Week 8 (n=0, 189, 187) | -128.9 μm | Standard Error 5.82 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 32 (n=0, 189, 187) | -156.0 μm | Standard Error 6.35 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 24 (n=0, 189, 187) | -156.2 μm | Standard Error 6.3 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 44 (n=0, 189, 187) | -162.2 μm | Standard Error 6.17 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 6 (n=0, 189, 187) | -116.1 μm | Standard Error 5.89 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 36 (n=0, 189, 187) | -135.1 μm | Standard Error 7.01 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 18 (n=0, 189, 187) | -144.2 μm | Standard Error 5.96 |
| Brolucizumab 6 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 20 (n=0, 189, 187) | -153.8 μm | Standard Error 5.71 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 52 (n=0, 189, 187) | -160.4 μm | Standard Error 6.21 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 4 (n=190, 0, 187) | -104.1 μm | Standard Error 6.15 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 4 (n=0, 189, 187) | -103.4 μm | Standard Error 5.95 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 6 (n=190, 0, 187) | -119.3 μm | Standard Error 6.29 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 6 (n=0, 189, 187) | -118.6 μm | Standard Error 5.92 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 8 (n=190, 0, 187) | -126.1 μm | Standard Error 6.11 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg)- Week 8 (n=0, 189, 187) | -125.6 μm | Standard Error 5.86 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 12 (n=190, 0, 187) | -137.4 μm | Standard Error 6.19 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 12 (n=0, 189, 187) | -137.3 μm | Standard Error 6.26 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 16 (n=190, 0, 187) | -143.3 μm | Standard Error 6.02 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 16 (n=0, 189, 187) | -143.1 μm | Standard Error 5.86 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 18 (n=190, 0, 187) | -147.0 μm | Standard Error 6.32 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 18 (n=0, 189, 187) | -146.8 μm | Standard Error 5.99 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 20 (n=190, 0, 187) | -148.3 μm | Standard Error 6.06 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 20 (n=0, 189, 187) | -148.0 μm | Standard Error 5.74 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 24 (n=190, 0, 187) | -138.7 μm | Standard Error 6.42 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 24 (n=0, 189, 187) | -138.4 μm | Standard Error 6.33 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 28 (n=190, 0, 187) | -154.6 μm | Standard Error 5.85 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 28 (n=0, 189, 187) | -154.6 μm | Standard Error 6 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 32 (n=190, 0, 187) | -144.3 μm | Standard Error 6.73 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 32 (n=0, 189, 187) | -144.2 μm | Standard Error 6.38 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 36 (n=190, 0, 187) | -156.0 μm | Standard Error 7.81 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 36 (n=0, 189, 187) | -155.5 μm | Standard Error 7.05 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 40 (n=190, 0, 187) | -149.7 μm | Standard Error 6.51 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 40 (n=0, 189, 187) | -150.4 μm | Standard Error 6.72 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 44 (n=190, 0, 187) | -163.4 μm | Standard Error 6.62 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 44 (n=0, 189, 187) | -163.3 μm | Standard Error 6.21 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 48 (n=190, 0, 187) | -157.8 μm | Standard Error 6.98 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 48 (n=0, 189, 187) | -158.2 μm | Standard Error 6.55 |
| Aflibercept 2 mg | Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results | LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 52 (n=190, 0, 187) | -160.7 μm | Standard Error 6.75 |
Comparison: Week 495% CI: [-17.7, 16.4]ANOVA
Comparison: Week 495% CI: [-18.7, 14.4]ANOVA
Comparison: Week 695% CI: [-5.2, 29.7]ANOVA
Comparison: Week 695% CI: [-14, 18.9]ANOVA
Comparison: Week 895% CI: [-16, 17.9]ANOVA
Comparison: Week 895% CI: [-19.6, 12.9]ANOVA
Comparison: Week 1295% CI: [-10.7, 23.6]ANOVA
Comparison: Week 1295% CI: [-14.6, 20.2]ANOVA
Comparison: Week 1695% CI: [-15.7, 17.8]ANOVA
Comparison: Week 1695% CI: [-19.7, 12.9]ANOVA
Comparison: Week 1895% CI: [-8.6, 26.5]ANOVA
Comparison: Week 1895% CI: [-14.1, 19.2]ANOVA
Comparison: Week 2095% CI: [-20.2, 13.4]ANOVA
Comparison: Week 2095% CI: [-21.7, 10.2]ANOVA
Comparison: Week 2495% CI: [-31.7, 3.9]ANOVA
Comparison: Week 2495% CI: [-35.4, -0.2]ANOVA
Comparison: Week 2895% CI: [-25, 7.5]ANOVA
Comparison: Week 2895% CI: [-25.4, 8]ANOVA
Comparison: Week 3295% CI: [-21.8, 15.5]ANOVA
Comparison: Week 3295% CI: [-29.5, 6]ANOVA
Comparison: Week 3695% CI: [14.6, 57.9]ANOVA
Comparison: Week 3695% CI: [0.7, 40]ANOVA
Comparison: Week 4095% CI: [-24.2, 11.9]ANOVA
Comparison: Week 4095% CI: [-25.2, 12.2]ANOVA
Comparison: Week 4495% CI: [-10.4, 26.3]ANOVA
Comparison: Week 4495% CI: [-16.2, 18.3]ANOVA
Comparison: Week 4895% CI: [-5.8, 32.9]ANOVA
Comparison: Week 4895% CI: [-13.5, 23]ANOVA
Comparison: Week 5295% CI: [-14.5, 23]ANOVA
Comparison: Week 5295% CI: [-22.3, 12.2]ANOVA
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 28 | 2.6 overall scores | Standard Deviation 14.37 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 52 (n = 148,147,152) | 2.0 overall scores | Standard Deviation 16.11 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 76 (n = 131,137,140) | 1.7 overall scores | Standard Deviation 13.58 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 100 (n=139,138,138) | 2.0 overall scores | Standard Deviation 14.14 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 100 (n=139,138,138) | 1.3 overall scores | Standard Deviation 15.79 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 28 | 2.6 overall scores | Standard Deviation 18.2 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 76 (n = 131,137,140) | 0.2 overall scores | Standard Deviation 17.01 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 52 (n = 148,147,152) | 2.0 overall scores | Standard Deviation 12.59 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 100 (n=139,138,138) | 0.5 overall scores | Standard Deviation 16.94 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 52 (n = 148,147,152) | 1.6 overall scores | Standard Deviation 15.13 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 76 (n = 131,137,140) | 0.2 overall scores | Standard Deviation 13.9 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision | Week 28 | 1.8 overall scores | Standard Deviation 14.49 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 76 (n = 133,138,143) | 6.7 overall scores | Standard Deviation 13.21 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 100 (n=140,141,142) | 6.6 overall scores | Standard Deviation 15.16 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 52 (n = 151,148,157) | 4.6 overall scores | Standard Deviation 12.89 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 28 | 5.5 overall scores | Standard Deviation 11.89 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 28 | 6.0 overall scores | Standard Deviation 14.27 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 52 (n = 151,148,157) | 6.7 overall scores | Standard Deviation 13.24 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 100 (n=140,141,142) | 6.5 overall scores | Standard Deviation 14.41 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 76 (n = 133,138,143) | 5.8 overall scores | Standard Deviation 14.5 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 100 (n=140,141,142) | 6.2 overall scores | Standard Deviation 13.16 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 28 | 7.8 overall scores | Standard Deviation 12.68 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 52 (n = 151,148,157) | 8.5 overall scores | Standard Deviation 12.99 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score | Week 76 (n = 133,138,143) | 7.1 overall scores | Standard Deviation 12.49 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 28 | 6.3 overall scores | Standard Deviation 21.8 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 52 (n = 151,148,157) | 3.8 overall scores | Standard Deviation 23.05 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 76 (n = 133,138,143) | 5.2 overall scores | Standard Deviation 22.93 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 100 (n=140,141,142) | 5.5 overall scores | Standard Deviation 24.89 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 100 (n=140,141,142) | 3.2 overall scores | Standard Deviation 25.79 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 28 | 6.1 overall scores | Standard Deviation 25.16 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 76 (n = 133,138,143) | 4.2 overall scores | Standard Deviation 25.56 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 52 (n = 151,148,157) | 4.1 overall scores | Standard Deviation 25.36 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 100 (n=140,141,142) | 5.6 overall scores | Standard Deviation 25.35 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 52 (n = 151,148,157) | 9.0 overall scores | Standard Deviation 22.68 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 76 (n = 133,138,143) | 6.8 overall scores | Standard Deviation 22.59 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency | Week 28 | 7.1 overall scores | Standard Deviation 22.06 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 28 | 6.0 overall scores | Standard Deviation 18.39 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 52 (n = 151,148,157) | 4.2 overall scores | Standard Deviation 22.2 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 76 (n = 133,138,143) | 8.3 overall scores | Standard Deviation 20.45 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 100 (n=140,141,142) | 6.4 overall scores | Standard Deviation 20.68 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 100 (n=140,141,142) | 7.0 overall scores | Standard Deviation 19.24 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 28 | 7.9 overall scores | Standard Deviation 21.58 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 76 (n = 133,138,143) | 8.1 overall scores | Standard Deviation 19.2 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 52 (n = 151,148,157) | 9.0 overall scores | Standard Deviation 19.42 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 100 (n=140,141,142) | 6.7 overall scores | Standard Deviation 19.15 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 52 (n = 151,148,157) | 9.9 overall scores | Standard Deviation 20.05 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 76 (n = 133,138,143) | 7.0 overall scores | Standard Deviation 18.39 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities | Week 28 | 9.0 overall scores | Standard Deviation 19.35 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 28 | 4.7 overall scores | Standard Deviation 16.4 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 52 (n = 97,98,91) | 5.2 overall scores | Standard Deviation 16.51 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 76 (n = 86,86,83) | 5.5 overall scores | Standard Deviation 16.09 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 100 (n=86,86,81) | 6.2 overall scores | Standard Deviation 16.58 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 100 (n=86,86,81) | 4.3 overall scores | Standard Deviation 20.24 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 28 | 1.9 overall scores | Standard Deviation 17.74 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 76 (n = 86,86,83) | 2.9 overall scores | Standard Deviation 18.34 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 52 (n = 97,98,91) | 3.6 overall scores | Standard Deviation 18.73 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 100 (n=86,86,81) | 2.3 overall scores | Standard Deviation 18.84 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 52 (n = 97,98,91) | 6.4 overall scores | Standard Deviation 17.64 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 76 (n = 86,86,83) | 6.5 overall scores | Standard Deviation 19.13 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving | Week 28 | 6.7 overall scores | Standard Deviation 15.06 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 28 | 0.9 overall scores | Standard Deviation 19.5 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 52 (n = 151,148,157) | 4.3 overall scores | Standard Deviation 22.5 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 76 (n = 133, 138, 143) | 2.3 overall scores | Standard Deviation 23.53 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 100 (n=140, 141, 142) | 2.3 overall scores | Standard Deviation 23.97 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 100 (n=140, 141, 142) | 6.9 overall scores | Standard Deviation 23.55 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 28 | 3.0 overall scores | Standard Deviation 22.1 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 76 (n = 133, 138, 143) | 6.3 overall scores | Standard Deviation 24.18 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 52 (n = 151,148,157) | 6.8 overall scores | Standard Deviation 22.32 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 100 (n=140, 141, 142) | 8.8 overall scores | Standard Deviation 21.72 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 52 (n = 151,148,157) | 6.8 overall scores | Standard Deviation 24.94 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 76 (n = 133, 138, 143) | 8.2 overall scores | Standard Deviation 20.93 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating | Week 28 | 6.1 overall scores | Standard Deviation 19.25 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 28 | 7.8 overall scores | Standard Deviation 14.75 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 52 (n = 151,148,157) | 6.6 overall scores | Standard Deviation 14.74 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 76 (n = 133,138,143) | 7.5 overall scores | Standard Deviation 14.89 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 100 (n=140,141,142) | 10.4 overall scores | Standard Deviation 17.87 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 100 (n=140,141,142) | 13.5 overall scores | Standard Deviation 17.97 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 28 | 10.8 overall scores | Standard Deviation 18.11 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 76 (n = 133,138,143) | 10.0 overall scores | Standard Deviation 17.8 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 52 (n = 151,148,157) | 11.2 overall scores | Standard Deviation 17.18 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 100 (n=140,141,142) | 11.5 overall scores | Standard Deviation 16.21 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 52 (n = 151,148,157) | 10.7 overall scores | Standard Deviation 17.62 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 76 (n = 133,138,143) | 11.7 overall scores | Standard Deviation 17.97 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision | Week 28 | 11.3 overall scores | Standard Deviation 15.88 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 28 | 7.8 overall scores | Standard Deviation 20.63 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 52 (n = 151,148,157) | 7.9 overall scores | Standard Deviation 22.93 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 76 (n = 133,138,143) | 10.3 overall scores | Standard Deviation 21.07 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 100 (n=140,141,142) | 11.7 overall scores | Standard Deviation 25.28 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 100 (n=140,141,142) | 9.4 overall scores | Standard Deviation 23.62 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 28 | 8.2 overall scores | Standard Deviation 22.21 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 76 (n = 133,138,143) | 11.5 overall scores | Standard Deviation 21.1 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 52 (n = 151,148,157) | 9.6 overall scores | Standard Deviation 21.42 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 100 (n=140,141,142) | 10.9 overall scores | Standard Deviation 22.22 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 52 (n = 151,148,157) | 11.3 overall scores | Standard Deviation 21.34 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 76 (n = 133,138,143) | 11.2 overall scores | Standard Deviation 20.93 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health | Week 28 | 8.7 overall scores | Standard Deviation 19.71 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 28 | 8.4 overall scores | Standard Deviation 19.83 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 52 (n = 151,148,157) | 8.1 overall scores | Standard Deviation 21.41 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 76 (n = 133,138,143) | 11.7 overall scores | Standard Deviation 20 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 100 (n=140,141,142) | 11.6 overall scores | Standard Deviation 22.23 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 100 (n=140,141,142) | 15.7 overall scores | Standard Deviation 22.01 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 28 | 13.2 overall scores | Standard Deviation 24.93 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 76 (n = 133,138,143) | 14.9 overall scores | Standard Deviation 23.35 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 52 (n = 151,148,157) | 14.1 overall scores | Standard Deviation 24.17 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 100 (n=140,141,142) | 10.4 overall scores | Standard Deviation 23.5 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 52 (n = 151,148,157) | 13.4 overall scores | Standard Deviation 23.64 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 76 (n = 133,138,143) | 12.4 overall scores | Standard Deviation 20.92 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities | Week 28 | 13.7 overall scores | Standard Deviation 20.51 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 28 | 2.2 overall scores | Standard Deviation 21.02 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 52 (n = 151,148,157) | 1.0 overall scores | Standard Deviation 19.55 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 76 (n = 133,138,143) | 4.1 overall scores | Standard Deviation 19.75 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 100 (n=140,141,142) | 3.1 overall scores | Standard Deviation 19.9 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 100 (n=140,141,142) | 3.1 overall scores | Standard Deviation 18.37 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 28 | 2.4 overall scores | Standard Deviation 21.92 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 76 (n = 133,138,143) | 2.1 overall scores | Standard Deviation 22.78 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 52 (n = 151,148,157) | 4.9 overall scores | Standard Deviation 19.54 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 100 (n=140,141,142) | 2.0 overall scores | Standard Deviation 19.73 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 52 (n = 151,148,157) | 5.3 overall scores | Standard Deviation 22.16 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 76 (n = 133,138,143) | 3.9 overall scores | Standard Deviation 21.72 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain | Week 28 | 4.3 overall scores | Standard Deviation 23.61 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 28 | 3.6 overall scores | Standard Deviation 20.89 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 52 (n = 151,148,156) | 1.3 overall scores | Standard Deviation 22.51 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 76 (n = 133, 138, 143) | 5.6 overall scores | Standard Deviation 21.01 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 100 (n=140, 140, 142) | 3.4 overall scores | Standard Deviation 21.87 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 100 (n=140, 140, 142) | -0.4 overall scores | Standard Deviation 24.36 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 28 | 1.6 overall scores | Standard Deviation 22.05 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 76 (n = 133, 138, 143) | 1.1 overall scores | Standard Deviation 24.33 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 52 (n = 151,148,156) | 4.1 overall scores | Standard Deviation 22.97 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 100 (n=140, 140, 142) | 6.3 overall scores | Standard Deviation 24.81 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 52 (n = 151,148,156) | 8.5 overall scores | Standard Deviation 22.98 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 76 (n = 133, 138, 143) | 7.3 overall scores | Standard Deviation 20.94 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision | Week 28 | 9.2 overall scores | Standard Deviation 22.82 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 28 | 8.0 overall scores | Standard Deviation 24.93 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 52 (n = 151,148,157) | 6.9 overall scores | Standard Deviation 23.88 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 76 (n = 133,138,143) | 9.9 overall scores | Standard Deviation 25.1 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 100 (n=140,141,142) | 9.3 overall scores | Standard Deviation 28.27 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 100 (n=140,141,142) | 9.6 overall scores | Standard Deviation 28.88 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 28 | 6.5 overall scores | Standard Deviation 26.81 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 76 (n = 133,138,143) | 6.8 overall scores | Standard Deviation 29.48 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 52 (n = 151,148,157) | 6.1 overall scores | Standard Deviation 29.11 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 100 (n=140,141,142) | 6.9 overall scores | Standard Deviation 26.19 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 52 (n = 151,148,157) | 11.3 overall scores | Standard Deviation 25.47 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 76 (n = 133,138,143) | 7.4 overall scores | Standard Deviation 27.76 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties | Week 28 | 9.4 overall scores | Standard Deviation 27.34 |
Secondary
Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: FAS - Observed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 28 | 2.7 overall scores | Standard Deviation 17.79 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 52 (n = 151,148,157) | 3.1 overall scores | Standard Deviation 18.82 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 76 (n = 133,138,143) | 3.6 overall scores | Standard Deviation 17.24 |
| Brolucizumab 3 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 100 (n=140,141,142) | 2.5 overall scores | Standard Deviation 19.68 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 100 (n=140,141,142) | 2.0 overall scores | Standard Deviation 21.82 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 28 | 2.2 overall scores | Standard Deviation 18 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 76 (n = 133,138,143) | 0.5 overall scores | Standard Deviation 18.95 |
| Brolucizumab 6 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 52 (n = 151,148,157) | 2.7 overall scores | Standard Deviation 17.53 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 100 (n=140,141,142) | 1.4 overall scores | Standard Deviation 16.38 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 52 (n = 151,148,157) | 3.8 overall scores | Standard Deviation 15.98 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 76 (n = 133,138,143) | 1.7 overall scores | Standard Deviation 16.49 |
| Aflibercept 2 mg | Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning | Week 28 | 3.9 overall scores | Standard Deviation 14.15 |
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 44 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 60 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 59 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 53 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 55 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 55 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 61 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 49 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 54 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 39 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 40 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 51 Participants |
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 27 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 29 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 23 Participants |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 24 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 40 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 39 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 44 Participants |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 32 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 100 | 41 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 28 | 22 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 52 | 30 Participants |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects | Week 76 | 42 Participants |
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a \>=2-step Improvement From Baseline in the DRSS Score from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185,0, 184) | 23.3 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 185,0, 184) | 28.0 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185,0, 184) | 31.2 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185,0, 184) | 31.7 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | 29.0 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 76 (n = 0, 186, 184) | 29.0 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 28 (n = 0, 186, 184) | 25.8 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 100 (n = 0, 186, 184) | 32.1 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 76 (n = 0, 186, 184) | 28.3 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 100 (n = 0, 186, 184) | 30.0 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185,0, 184) | 21.7 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185,0, 184) | 30.1 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 28 (n = 0, 186, 184) | 21.7 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 185,0, 184) | 22.3 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | 22.2 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185,0, 184) | 28.4 Percentage estimates |
95% CI: [-5.3, 8.4]Bootstrap method
95% CI: [-2.1, 10.3]Bootstrap method
95% CI: [-1.2, 12.4]Bootstrap method
95% CI: [0.6, 12.9]Bootstrap method
95% CI: [-3.9, 9.4]Bootstrap method
95% CI: [-5.7, 7]Bootstrap method
95% CI: [-5, 8.1]Bootstrap method
95% CI: [-4, 8.4]Bootstrap method
Secondary
Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates
Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning. * estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept. * estimates represent the % of participants who were estimated to have a \>=3-step Improvement From Baseline in the DRSS Score from pairwise logistic regression models adjusting for baseline DRSS score categories (\<=4, ≥5), age categories (\<65, ≥65 years) and treatment as fixed effect factors. Abbreviation: Proportion Estimates = P.E.
Time frame: Baseline, Weeks 28, 52, 76, 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185, 0, 184) | 12.1 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E.(%) at Week 52 (n = 185, 0, 184) | 12.6 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185, 0, 184) | 14.2 Percentage estimates |
| Brolucizumab 3 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185, 0, 184) | 15.2 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | 20.5 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 0, 186, 184) | 21.1 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 0, 186, 184) | 16.8 Percentage estimates |
| Brolucizumab 6 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 0, 186, 184) | 23.2 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 0, 186, 184) | 23.3 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 0, 186, 184) | 22.8 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185, 0, 184) | 12.3 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185, 0, 184) | 22.9 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 0, 186, 184) | 12.2 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E.(%) at Week 52 (n = 185, 0, 184) | 16.8 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184) | 16.7 Percentage estimates |
| Aflibercept 2 mg | Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates | Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185, 0, 184) | 23.4 Percentage estimates |
95% CI: [-6.4, 5.8]Bootstrap method
95% CI: [-1.3, 11]Bootstrap method
95% CI: [-10.2, 2.2]Bootstrap method
95% CI: [-2.2, 10.5]Bootstrap method
95% CI: [-15.5, -2.8]Bootstrap method
95% CI: [-8.4, 4.4]Bootstrap method
95% CI: [-14, -1.6]Bootstrap method
95% CI: [-5.7, 6.8]Bootstrap method
Secondary
Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit
Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit
Time frame: Baseline, up to Week 52 and Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 32 | 143 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 100 | 87 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 68 | 109 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 36 | 153 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 4 | 176 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 64 | 102 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 40 | 129 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 16 | 155 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 60 | 119 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 44 | 127 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 96 | 92 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 56 | 111 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 48 | 132 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 88 | 89 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 52 | 113 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 18 | 152 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 8 | 166 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 84 | 102 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 20 | 142 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 6 | 177 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 80 | 96 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 24 | 142 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 92 | 91 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 76 | 98 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 28 | 139 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 12 | 167 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 72 | 107 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 88 | 85 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 4 | 169 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 6 | 169 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 8 | 161 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 12 | 162 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 16 | 150 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 18 | 149 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 20 | 147 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 24 | 140 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 28 | 130 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 32 | 131 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 36 | 141 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 40 | 114 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 44 | 118 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 48 | 123 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 52 | 114 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 56 | 103 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 60 | 115 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 64 | 105 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 68 | 98 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 72 | 103 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 76 | 96 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 80 | 85 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 84 | 92 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 92 | 86 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 96 | 90 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 100 | 79 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 32 | 156 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 4 | 169 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 68 | 118 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 28 | 144 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 92 | 105 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 72 | 126 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 24 | 153 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 6 | 169 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 76 | 118 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 20 | 145 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 100 | 101 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 80 | 120 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 18 | 154 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 96 | 107 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 84 | 108 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 48 | 147 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 16 | 156 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 52 | 137 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 44 | 135 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 12 | 165 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 56 | 138 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 40 | 150 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 88 | 114 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 60 | 126 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 36 | 144 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 8 | 164 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit | Week 64 | 131 Participants |
Secondary
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100
Assessed by angiography.
Time frame: Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 3 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | 94 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | 80 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100 | 104 Participants |
Secondary
Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52
Assessed by angiography.
Time frame: Week 52
Population: Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 3 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | 114 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | 108 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52 | 140 Participants |
Secondary
Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit
Time frame: Baseline, up to Week 52 and Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 32 | 143 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 100 | 87 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 68 | 109 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 36 | 153 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 4 | 177 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 64 | 102 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 40 | 129 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 16 | 156 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 60 | 120 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 44 | 127 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 96 | 92 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 56 | 111 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 48 | 132 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 88 | 89 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 52 | 113 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 18 | 153 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 8 | 166 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 84 | 102 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 20 | 142 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 6 | 177 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 80 | 96 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 24 | 142 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 92 | 91 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 76 | 98 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 28 | 139 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 12 | 168 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 72 | 107 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 88 | 85 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 4 | 172 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 6 | 173 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 8 | 162 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 12 | 162 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 16 | 150 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 18 | 149 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 20 | 147 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 24 | 140 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 28 | 130 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 32 | 131 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 36 | 141 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 40 | 114 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 44 | 118 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 48 | 123 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 52 | 114 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 56 | 103 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 60 | 115 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 64 | 105 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 68 | 98 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 72 | 103 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 76 | 96 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 80 | 85 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 84 | 92 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 92 | 86 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 96 | 90 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 100 | 79 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 32 | 156 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 4 | 171 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 68 | 118 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 28 | 144 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 92 | 105 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 72 | 126 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 24 | 153 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 6 | 169 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 76 | 118 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 20 | 145 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 100 | 101 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 80 | 120 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 18 | 154 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 96 | 107 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 84 | 108 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 48 | 147 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 16 | 156 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 52 | 137 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 44 | 135 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 12 | 165 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 56 | 138 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 40 | 150 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 88 | 114 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 60 | 126 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 36 | 144 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 8 | 164 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit | Week 64 | 131 Participants |
Secondary
Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit
Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit
Time frame: Baseline up to Week 52 and Week 100
Population: Full analysis set (FAS) - Last observation carried forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 32 | 11 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 100 | 3 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 68 | 6 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 36 | 16 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 4 | 26 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 64 | 6 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 40 | 8 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week16 | 6 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 60 | 9 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 44 | 4 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 96 | 5 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 56 | 9 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 48 | 7 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 88 | 7 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 52 | 4 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week18 | 7 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 8 | 10 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 84 | 6 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 20 | 5 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 6 | 20 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 80 | 5 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 24 | 7 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 92 | 4 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 76 | 4 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 28 | 5 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 12 | 11 Participants |
| Brolucizumab 3 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 72 | 5 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 88 | 2 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 4 | 23 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 6 | 17 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 8 | 9 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 12 | 8 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week16 | 6 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week18 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 20 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 24 | 3 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 28 | 2 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 32 | 1 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 36 | 14 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 40 | 5 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 44 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 48 | 8 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 52 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 56 | 3 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 60 | 5 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 64 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 68 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 72 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 76 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 80 | 4 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 84 | 3 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 92 | 2 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 96 | 3 Participants |
| Brolucizumab 6 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 100 | 2 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 32 | 6 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 4 | 27 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 68 | 3 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 28 | 3 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 92 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 72 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 24 | 6 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 6 | 17 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 76 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 20 | 6 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 100 | 2 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 80 | 5 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week18 | 6 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 96 | 5 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 84 | 3 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 48 | 3 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week16 | 7 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 52 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 44 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 12 | 8 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 56 | 5 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 40 | 6 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 88 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 60 | 5 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 36 | 4 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 8 | 12 Participants |
| Aflibercept 2 mg | Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit | Week 64 | 5 Participants |
Secondary
Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)
Time frame: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
Population: Safety Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 3 mg | Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | 146 Participants |
| Brolucizumab 6 mg | Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | 146 Participants |
| Aflibercept 2 mg | Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) | 143 Participants |
Secondary
Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye
Time frame: Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Iridocyclitis | 4 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Intraocular pressure increased | 14 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye pain | 3 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctivitis | 4 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Retinal exudates | 7 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Posterior capsule opacification | 3 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival haemorrhage | 19 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Uveitis | 4 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye irritation | 3 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract subcapsular | 1 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous detachment | 9 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Blepharitis | 3 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Diabetic retinal oedema | 12 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival hyperaemia | 4 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Keratitis | 0 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Ocular hypertension | 4 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Number of subjects with at least one AE | 103 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous haemorrhage | 2 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreoretinal traction syndrome | 1 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous floaters | 7 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Punctate keratitis | 8 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Corneal abrasion | 3 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract | 17 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vision blurred | 6 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Dry eye | 10 Participants |
| Brolucizumab 3 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Visual acuity reduced | 7 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous floaters | 10 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Visual acuity reduced | 3 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Iridocyclitis | 2 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Ocular hypertension | 2 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Diabetic retinal oedema | 9 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Uveitis | 2 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival haemorrhage | 16 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Corneal abrasion | 1 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Retinal exudates | 1 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctivitis | 6 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract subcapsular | 0 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival hyperaemia | 0 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreoretinal traction syndrome | 0 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Dry eye | 6 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye pain | 6 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Intraocular pressure increased | 11 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Posterior capsule opacification | 6 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract | 16 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye irritation | 5 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Blepharitis | 4 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous detachment | 10 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Keratitis | 4 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Number of subjects with at least one AE | 92 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous haemorrhage | 4 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Punctate keratitis | 3 Participants |
| Brolucizumab 6 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vision blurred | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Punctate keratitis | 1 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract subcapsular | 4 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Number of subjects with at least one AE | 94 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract | 13 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival haemorrhage | 19 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Intraocular pressure increased | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous detachment | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous floaters | 6 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Diabetic retinal oedema | 4 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctivitis | 1 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Dry eye | 5 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye pain | 5 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Posterior capsule opacification | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Eye irritation | 4 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Blepharitis | 4 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Keratitis | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreous haemorrhage | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vision blurred | 1 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Visual acuity reduced | 9 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Iridocyclitis | 0 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Ocular hypertension | 2 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Uveitis | 0 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Corneal abrasion | 4 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Retinal exudates | 3 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival hyperaemia | 1 Participants |
| Aflibercept 2 mg | Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye | Vitreoretinal traction syndrome | 5 Participants |
Secondary
Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 8 weeks (q8w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Time frame: Weeks 36 and 48
Population: FAS - Efficacy/Safety approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 1 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.870 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 1 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.876 Probability |
Secondary
Patients Maintained at q12w - Probability of Maintaining on q12w
Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \[every 12 weeks (q12w)\]. This outcome measure is pre-specified for brolucizumab treatment arms only.
Time frame: Baseline (Week 0), Weeks 32, 36 and 48
Population: FAS - Efficacy/Safety approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 0.758 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 0.545 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.474 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.550 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 0.628 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 0.807 Probability |
Secondary
Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w
This outcome measure is pre-specified for brolucizumab treatment arms only
Time frame: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Population: FAS - Efficacy/Safety approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 0.758 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 0.545 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.474 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 60 | 0.403 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 72 | 0.394 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 84 | 0.365 Probability |
| Brolucizumab 3 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 96 | 0.334 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 96 | 0.441 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 60 | 0.520 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 0.807 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 84 | 0.460 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 0.628 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 72 | 0.487 Probability |
| Brolucizumab 6 mg | Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.550 Probability |
Secondary
Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w
This outcome measure is pre-specified for brolucizumab treatment arms only
Time frame: Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96
Population: FAS - Efficacy/Safety approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 60 | 0.740 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 1 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 1 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 84 | 0.670 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.870 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 96 | 0.613 Probability |
| Brolucizumab 3 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 72 | 0.723 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 96 | 0.702 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 0 | 1 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 32 | 1 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 36 | 1 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 48 | 0.876 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 60 | 0.828 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 72 | 0.775 Probability |
| Brolucizumab 6 mg | Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w | Prob. of maintaining on q12w - Week 84 | 0.732 Probability |