Neovascular Age-Related Macular Degeneration
Conditions
Keywords
Macular degeneration, age-related macular degeneration (AMD), vision loss, macula damage, retina damage, wet macular degeneration, AMD
Brief summary
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Detailed description
This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. The study included 14 scheduled visits over 48 weeks. After confirmation of eligibility at baseline, participants were randomized in a 1:1 ratio to one of the 2 treatment arms: * Brolucizumab 6 mg: 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status. * Aflibercept 2 mg: 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40. Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 16, 20, 32 and 44 to determine the regimen of brolucizumab arm (i.e., q12w or q8w).
Interventions
DRUGBrolucizumab 6mg
Intravitreal injection
DRUGAflibercept 2 mg
Intravitreal injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before any assessment was performed. * Male or female Chinese participants ≥ 50 years of age at the time of screening. * Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at screening and confirmed by the Central Reading Center (CRC). * Total area of CNV (including both classic and occult components) must comprise \> 50% of the total lesion area in the study eye at screening and confirmed by the CRC. * Intra and/or subretinal fluid affecting the central subfield of the study eye at screening and confirmed by the CRC. * BCVA between 78 and 23 letters, inclusive, in the study eye at screening and baseline using ETDRS testing.
Exclusion criteria
* Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at baseline. * Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at screening and confirmed by the CRC. * Total area of fibrosis ≥ 50% of the total lesion in the study eye at screening and confirmed by the CRC. * Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening and confirmed by the CRC. * Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements). * Retinal pigment epithelium rip/tear in the study eye at screening. * Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye | Baseline, Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability | Week 44 | The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event first q8w-need, applying a q8w-need allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis. The proportion of participants with a positive q12w treatment status was derived as follows according to the sufficient efficacy and safety approach: the q8w-need assessment was imputed as Yes at the disease activity assessment (DAA) visit following early treatment/study discontinuation due to lack of efficacy and /or lack of safety of the study treatment (applicable to both missing and non-missing DAAs). |
| q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability | Week 44 | The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event first q8w-need, applying a q8w-need allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis. The analysis of q12w treatment status within the participants randomized to brolucizumab 6 mg and with no q8w need during the first q12w cycle was based on the subset of FAS participants randomized to brolucizumab 6 mg with no identified q8w-need at Week 16 and Week 20. |
| Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit | Week 16 | For both arms, the treatment was initiated with 3 monthly injections at Weeks 0, 4 and 8 (loading phase). Week 12 was scheduled as a no injection visit for both arms per protocol. Therefore, by Week 16, the planned treatment exposure was identical between the treatment arms, allowing a matched comparison of brolucizumab and aflibercept up to 8 weeks after loading. |
| Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye | Baseline, over the period of Week 4 or Week 12 to Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Baseline up to Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Baseline up to Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Baseline, Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye | Baseline, over the period Week 4 through Week 48 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm. |
| Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye | Baseline, over the period Week 36 to Week 48 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm. |
| Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm. |
| Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. The central subfield thickness-neurosensory retina (CSFTns) is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the outer segment tips. The center subfield is the circular region centered on the anatomic fovea with the radius of 500μm. |
| Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | — |
| Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | Between Weeks 36 and Weeks 48 | — |
| Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | — |
| Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | — |
| Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | — |
| Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye | Baseline, Week 12 and Week 48 | — |
| Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Baseline, Week 12, Week 48 | As assessed by color fundus photography. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | Baseline, Week 24 and Week 48 | The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning. |
| Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm | Baseline | To assess immunogenicity of brolucizumab 6 mg. |
| Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm | Baseline up to Week 48 (End of Study) | To assess immunogenicity of brolucizumab 6 mg. |
| Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | The maximum (peak) observed serum drug concentration after single dose administration (mass x volume-1) |
| Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | The time to reach maximum (peak) serum drug concentration after single dose administration (time). Actual sampling times were taken into consideration for the pharmacokinetic (PK) analysis. |
| Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) |
| Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye | Baseline, over the period Week 36 to Week 48 | 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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | The elimination half-life associated with the terminal slope (lz) of a semi logarithmic concentration time curve (time). |
| Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | Apparent total body clearance of siremadlin from serum (CL/F) |
| Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | Apparent volume of distribution during terminal elimination phase (Vz/F) |
| Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. Treatment-emergent AEs are presented, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. |
| Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. Treatment-emergent AEs are counted, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment. |
| Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects | Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29 | The AUC from time zero to infinity (mass x time x volume-1) |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brolucizumab 6 mg 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status. | 199 |
| Aflibercept 2 mg 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40. | 198 |
| Total | 397 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 10 |
Baseline characteristics
| Characteristic | Aflibercept 2 mg | Total | Brolucizumab 6 mg |
|---|---|---|---|
| Age, Continuous | 68.0 Years STANDARD_DEVIATION 7.68 | 68.5 Years STANDARD_DEVIATION 7.64 | 69.1 Years STANDARD_DEVIATION 7.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 198 Participants | 397 Participants | 199 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 54 Participants | 124 Participants | 70 Participants |
| Sex: Female, Male Male | 144 Participants | 273 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 1 / 198 | 1 / 397 |
| other Total, other adverse events | 94 / 199 | 90 / 198 | 184 / 397 |
| serious Total, serious adverse events | 23 / 199 | 24 / 198 | 47 / 397 |
Outcome results
Primary
Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye | 9.9 Letters Read | Standard Error 0.82 |
| Aflibercept 2 mg | Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye | 10.9 Letters Read | Standard Error 0.82 |
p-value: 0.00690% CI: [-3, 0.9]ANOVA
Secondary
Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm
To assess immunogenicity of brolucizumab 6 mg.
Time frame: Baseline up to Week 48 (End of Study)
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm | ADA negative or ADA positive with no boost | 170 Participants |
| Brolucizumab 6 mg | Anti-drug Antibody (ADA): Frequency Distribution of Integrated ADA Status in the Brolucizumab Arm | Induced or Boosted | 27 Participants |
Secondary
Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm
To assess immunogenicity of brolucizumab 6 mg.
Time frame: Baseline
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm | Pre-dose ADA Status = Negative | 82 Participants |
| Brolucizumab 6 mg | Anti-drug Antibody (ADA): Frequency Distribution of Pre-dose ADA Status in the Brolucizumab Arm | Pre-dose ADA Status = Positive | 116 Participants |
Secondary
Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, over the period of Week 4 or Week 12 to Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye | Average change from baseline over the period Week 4 through Week 48 | 8.3 Letters Read | Standard Error 0.68 |
| Brolucizumab 6 mg | Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye | Average change from baseline over the period Week 12 through Week 48 | 8.9 Letters Read | Standard Error 0.73 |
| Aflibercept 2 mg | Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye | Average change from baseline over the period Week 4 through Week 48 | 9.6 Letters Read | Standard Error 0.68 |
| Aflibercept 2 mg | Average Change From Baseline in Best Corrected Visual Acuity (Letters Read) From Week 4 or Week 12 up to Week 48 for the Study Eye | Average change from baseline over the period Week 12 through Week 48 | 10.4 Letters Read | Standard Error 0.74 |
Secondary
Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, over the period Week 36 to Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye | 9.7 Letters Read | Standard Error 0.78 |
| Aflibercept 2 mg | Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye | 11.0 Letters Read | Standard Error 0.79 |
p-value: 0.00990% CI: [-3.2, 0.5]ANOVA
Secondary
Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.
Time frame: Baseline, over the period Week 36 to Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye | -187.9 μm | Standard Error 8.38 |
| Aflibercept 2 mg | Average Change From Baseline Over the Period Week 36 Through 48 in Central Subfield Thickness - Total in Study Eye | -167.2 μm | Standard Error 8.4 |
Secondary
Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.
Time frame: Baseline, over the period Week 4 through Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye | -181.2 μm | Standard Error 7.46 |
| Aflibercept 2 mg | Average Change From Baseline Over the Period Week 4 Through Week 48 in Central Subfield Thickness - Total in Study Eye | -161.9 μm | Standard Error 7.48 |
Secondary
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 16 | 8.3 Letters Read | Standard Error 0.74 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 28 | 9.1 Letters Read | Standard Error 0.77 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 12 | 7.4 Letters Read | Standard Error 0.69 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 32 | 9.2 Letters Read | Standard Error 0.78 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 20 | 8.2 Letters Read | Standard Error 0.78 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 36 | 9.1 Letters Read | Standard Error 0.79 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 8 | 6.1 Letters Read | Standard Error 0.61 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 40 | 9.7 Letters Read | Standard Error 0.79 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 24 | 8.3 Letters Read | Standard Error 0.81 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 44 | 10.0 Letters Read | Standard Error 0.8 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 4 | 3.9 Letters Read | Standard Error 0.58 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 44 | 11.2 Letters Read | Standard Error 0.8 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 4 | 4.2 Letters Read | Standard Error 0.58 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 8 | 6.5 Letters Read | Standard Error 0.61 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 12 | 8.4 Letters Read | Standard Error 0.69 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 16 | 9.4 Letters Read | Standard Error 0.74 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 20 | 10.5 Letters Read | Standard Error 0.79 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 24 | 10.0 Letters Read | Standard Error 0.81 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 28 | 11.0 Letters Read | Standard Error 0.77 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 32 | 10.7 Letters Read | Standard Error 0.78 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 36 | 11.1 Letters Read | Standard Error 0.8 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye | Week 40 | 10.9 Letters Read | Standard Error 0.79 |
Secondary
Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. The central subfield thickness-neurosensory retina (CSFTns) is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the outer segment tips. The center subfield is the circular region centered on the anatomic fovea with the radius of 500μm.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 4 | -57.2 μm | Standard Error 4.55 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 8 | -65.4 μm | Standard Error 4.94 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 12 | -68.6 μm | Standard Error 5.11 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 16 | -63.8 μm | Standard Error 5.22 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 20 | -60.8 μm | Standard Error 5.44 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 24 | -67.0 μm | Standard Error 5.22 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 28 | -67.2 μm | Standard Error 5.28 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 32 | -62.7 μm | Standard Error 5.26 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 36 | -69.2 μm | Standard Error 5.42 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 40 | -67.9 μm | Standard Error 5.45 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 44 | -67.8 μm | Standard Error 5.53 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 48 | -69.7 μm | Standard Error 5.38 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 44 | -57.2 μm | Standard Error 5.54 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 4 | -48.3 μm | Standard Error 4.57 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 28 | -54.5 μm | Standard Error 5.29 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 8 | -53.2 μm | Standard Error 4.95 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 40 | -52.7 μm | Standard Error 5.46 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 12 | -53.2 μm | Standard Error 5.12 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 32 | -50.1 μm | Standard Error 5.27 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 16 | -48.4 μm | Standard Error 5.24 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 48 | -53.0 μm | Standard Error 5.39 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 20 | -56.4 μm | Standard Error 5.45 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 36 | -56.3 μm | Standard Error 5.43 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Neurosensory Retina (μm) in Study Eye | Week 24 | -49.9 μm | Standard Error 5.23 |
Secondary
Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye
Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. Central subfield thickness (CSFT) is a key anatomical parameter of central macula and is the average thickness in the center subfield as measured from the Internal Limiting Membrane (ILM) to the Bruch's Membrane (BM). The center subfield is the circular region centered on the anatomic fovea with the radius of 500 μm.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 28 | -186.8 μm | Standard Error 8.06 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 8 | -183.3 μm | Standard Error 6.95 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 32 | -174.0 μm | Standard Error 8.37 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 16 | -179.5 μm | Standard Error 7.99 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 36 | -191.2 μm | Standard Error 8.29 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 4 | -148.5 μm | Standard Error 6.5 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 40 | -184.6 μm | Standard Error 8.57 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 20 | -172.2 μm | Standard Error 7.91 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 44 | -184.7 μm | Standard Error 8.64 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 24 | -185.2 μm | Standard Error 8.33 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 48 | -191.1 μm | Standard Error 8.71 |
| Brolucizumab 6 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 12 | -193.2 μm | Standard Error 7.22 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 48 | -163.2 μm | Standard Error 8.73 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 4 | -132.5 μm | Standard Error 6.51 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 8 | -161.8 μm | Standard Error 6.97 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 12 | -169.9 μm | Standard Error 7.24 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 16 | -152.6 μm | Standard Error 8.01 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 24 | -152.0 μm | Standard Error 8.35 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 28 | -172.0 μm | Standard Error 8.08 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 32 | -157.2 μm | Standard Error 8.39 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 36 | -171.3 μm | Standard Error 8.31 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 40 | -159.0 μm | Standard Error 8.59 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 44 | -175.3 μm | Standard Error 8.66 |
| Aflibercept 2 mg | Change From Baseline at Each Study Visit in Central Subfield Thickness - Total in Study Eye | Week 20 | -175.6 μm | Standard Error 7.93 |
Secondary
Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye
Time frame: Baseline, Week 12 and Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye | Week 12 | -1.395 mm^2 | Standard Error 0.1613 |
| Brolucizumab 6 mg | Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye | Week 48 | -2.034 mm^2 | Standard Error 0.2002 |
| Aflibercept 2 mg | Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye | Week 12 | -1.378 mm^2 | Standard Error 0.1617 |
| Aflibercept 2 mg | Change From Baseline at Weeks 12 and 48 in Choroidal Neovascularization (CNV) Lesion in Study Eye | Week 48 | -1.984 mm^2 | Standard Error 0.2007 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | Week 24 | 1.3 Scores on a Scale | Standard Deviation 12.95 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | Week 48 (n=161,155) | 0.6 Scores on a Scale | Standard Deviation 15.55 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | Week 24 | 2.2 Scores on a Scale | Standard Deviation 18.36 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Color Vision | Week 48 (n=161,155) | 0.5 Scores on a Scale | Standard Deviation 14.93 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score | Week 24 | 3.0 Scores on a Scale | Standard Deviation 13.03 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score | Week 48 (n=165,159) | 4.1 Scores on a Scale | Standard Deviation 14 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score | Week 24 | 3.7 Scores on a Scale | Standard Deviation 12.94 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Composite Score | Week 48 (n=165,159) | 2.9 Scores on a Scale | Standard Deviation 13.69 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency | Week 24 | 3.9 Scores on a Scale | Standard Deviation 28.38 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency | Week 48 (n=165,159) | 6.6 Scores on a Scale | Standard Deviation 27.85 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency | Week 24 | 2.1 Scores on a Scale | Standard Deviation 24.29 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Dependency | Week 48 (n=165,159) | 0.6 Scores on a Scale | Standard Deviation 26.5 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | Week 24 | 2.2 Scores on a Scale | Standard Deviation 21.09 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | Week 48 (n=163,159) | 3.8 Scores on a Scale | Standard Deviation 20.62 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | Week 24 | 4.2 Scores on a Scale | Standard Deviation 20.07 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Distance Activities | Week 48 (n=163,159) | 4.8 Scores on a Scale | Standard Deviation 21.11 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving | Week 24 (n=33, 43) | 3.4 Scores on a Scale | Standard Deviation 15.5 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving | Week 48 (n=34,37) | 3.9 Scores on a Scale | Standard Deviation 17.28 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving | Week 24 (n=33, 43) | 0.8 Scores on a Scale | Standard Deviation 19.65 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Driving | Week 48 (n=34,37) | 4.6 Scores on a Scale | Standard Deviation 15.8 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | Week 24 | -3.6 Scores on a Scale | Standard Deviation 24.13 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | Week 48 (n=165,159) | -4.4 Scores on a Scale | Standard Deviation 24.84 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | Week 24 | 0.7 Scores on a Scale | Standard Deviation 24 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Health Rating | Week 48 (n=165,159) | -2.7 Scores on a Scale | Standard Deviation 26.62 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision | Week 24 | 7.7 Scores on a Scale | Standard Deviation 17.88 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision | Week 48 (n=165,159) | 9.0 Scores on a Scale | Standard Deviation 19.68 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision | Week 24 | 7.8 Scores on a Scale | Standard Deviation 17.47 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - General Vision | Week 48 (n=165,159) | 6.4 Scores on a Scale | Standard Deviation 16.89 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | Week 24 | 4.6 Scores on a Scale | Standard Deviation 25.61 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | Week 48 (n=165,159) | 4.7 Scores on a Scale | Standard Deviation 22.46 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | Week 24 | 0.6 Scores on a Scale | Standard Deviation 20.34 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Mental Health | Week 48 (n=165,159) | 1.0 Scores on a Scale | Standard Deviation 21.55 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | Week 24 | 5.3 Scores on a Scale | Standard Deviation 22.02 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | Week 48 (n=162,157) | 8.1 Scores on a Scale | Standard Deviation 23.28 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | Week 24 | 5.8 Scores on a Scale | Standard Deviation 21.03 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Near Activities | Week 48 (n=162,157) | 5.7 Scores on a Scale | Standard Deviation 22.64 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | Week 24 | 0.9 Scores on a Scale | Standard Deviation 17.68 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | Week 48 (n=165,159) | 1.0 Scores on a Scale | Standard Deviation 19.37 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | Week 24 | 6.1 Scores on a Scale | Standard Deviation 15.74 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Ocular Pain | Week 48 (n=165,159) | 3.1 Scores on a Scale | Standard Deviation 17.88 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | Week 24 | 1.6 Scores on a Scale | Standard Deviation 17.76 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | Week 48 (n=164,158) | 0.5 Scores on a Scale | Standard Deviation 18.67 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | Week 24 | 2.4 Scores on a Scale | Standard Deviation 16.92 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Peripheral Vision | Week 48 (n=164,158) | 1.4 Scores on a Scale | Standard Deviation 19.6 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties | Week 24 | 0.5 Scores on a Scale | Standard Deviation 27.25 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties | Week 48 (n=165,159) | 4.5 Scores on a Scale | Standard Deviation 25.23 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties | Week 24 | 3.8 Scores on a Scale | Standard Deviation 25.91 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Role Difficulties | Week 48 (n=165,159) | 2.7 Scores on a Scale | Standard Deviation 25.68 |
Secondary
Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning
The VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score was calculated by averaging vision-targeted subscale scores, excluding the general health rating question. All items are scored so that a high score represents better visual functioning.
Time frame: Baseline, Week 24 and Week 48
Population: Full Analysis Set - Observed - for participants with a valid measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | Week 24 | 1.5 Scores on a Scale | Standard Deviation 13.44 |
| Brolucizumab 6 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | Week 48 (n=165,159) | 2.3 Scores on a Scale | Standard Deviation 14.9 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | Week 24 | 2.4 Scores on a Scale | Standard Deviation 14.5 |
| Aflibercept 2 mg | Change in Subject Reported Outcomes (Visual Function Questionnaire-25) - Social Functioning | Week 48 (n=165,159) | 0.8 Scores on a Scale | Standard Deviation 15.83 |
Secondary
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 39 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 57 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 79 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 88 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 86 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 90 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 91 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 95 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 94 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 102 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 101 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 103 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 107 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 35 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 108 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 59 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 98 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 85 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 107 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 93 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 104 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 107 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 108 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 10 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 98 Participants |
Secondary
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 21 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 37 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 49 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 56 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 57 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 57 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 61 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 62 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 64 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 66 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 63 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 68 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 69 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 19 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 64 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 28 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 68 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 48 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 64 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 55 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 73 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 59 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 69 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 54 Participants |
Secondary
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline up to Week 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 5 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 139 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 10 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 103 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 15 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 68 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 5 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 146 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 10 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 104 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA ≥ 84 Letters at Week 48 for the Study Eye | Participants with ≥ 15 letters gain from baseline or reached BCVA of ≥ 84 letters at Week 48 | 73 Participants |
Secondary
Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 73 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 102 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 122 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 134 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 133 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 129 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 134 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 131 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 129 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 134 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 136 Participants |
| Brolucizumab 6 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 139 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 44 | 151 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 4 | 94 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 28 | 147 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 8 | 115 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 40 | 152 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 12 | 139 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 32 | 154 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 16 | 149 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 48 | 146 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 20 | 147 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 36 | 151 Participants |
| Aflibercept 2 mg | Gain in BCVA (Letters Read): Number (%) of Participants Who Gained ≥ 5 Letters in Best-correct Visual Acuity From Baseline or Reached BCVA >=84 Letters at the Post-baseline Visit for the Study Eye | Week 24 | 149 Participants |
Secondary
Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 8 | 15 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 28 | 15 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 16 | 13 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 32 | 23 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 4 | 26 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 36 | 17 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 20 | 23 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 40 | 21 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 12 | 15 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 44 | 22 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 24 | 15 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 48 | 16 Participants |
| Brolucizumab 6 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Baseline | 83 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 48 | 13 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Baseline | 81 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 4 | 17 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 8 | 13 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 12 | 13 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 16 | 22 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 20 | 10 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 24 | 19 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 28 | 9 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 32 | 14 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 36 | 6 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 40 | 13 Participants |
| Aflibercept 2 mg | Intraretinal Fluid (IRF) Status in the Central Subfield: Number of Subjects With Presence of IRF by Visit for the Study Eye | Week 44 | 7 Participants |
Secondary
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 5 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 9 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 13 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 8 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 9 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 8 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 7 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 7 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 6 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 6 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 6 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 6 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 10 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 5 Participants |
Secondary
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 2 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 2 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 5 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 7 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 9 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 5 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 5 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 6 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 5 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 3 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 3 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 3 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 3 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 4 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 2 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 15 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 3 Participants |
Secondary
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Week 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 5 letters loss from baseline at Week 48 | 16 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 10 letters loss from baseline at Week 48 | 7 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 15 letters loss from baseline at Week 48 | 5 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 5 letters loss from baseline at Week 48 | 11 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 10 letters loss from baseline at Week 48 | 6 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5, ≥ 10 and ≥ 15 Letters in Best-correct Visual Acuity From Baseline at Week 48 for the Study Eye | Participants with ≥ 15 letters loss from baseline at Week 48 | 4 Participants |
Secondary
Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 20 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 19 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 14 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 18 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 20 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 18 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 17 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 14 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 15 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 13 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 14 Participants |
| Brolucizumab 6 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 16 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 44 | 9 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 4 | 15 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 28 | 9 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 8 | 15 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 40 | 10 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 12 | 8 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 32 | 13 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 16 | 10 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 48 | 11 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 20 | 8 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 36 | 10 Participants |
| Aflibercept 2 mg | Loss in BCVA (Letters Read): Number (%) of Participants Who Lost ≥ 5 Letters in Best-correct Visual Acuity From Baseline to Each Post-baseline Visit for the Study | Week 24 | 13 Participants |
Secondary
Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. Treatment-emergent AEs are presented, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.
Time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Visual acuity reduced | 7 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctivitis | 5 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival haemorrhage | 7 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Dry eye | 5 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Retinal haemorrhage | 6 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract | 4 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Intraocular pressure increased | 10 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Meibomian gland dysfunction | 4 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Uveitis | 6 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Xerophthalmia | 4 Participants |
| Brolucizumab 6 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Number of participants with at least one AE | 58 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Xerophthalmia | 2 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Number of participants with at least one AE | 48 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Intraocular pressure increased | 6 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctival haemorrhage | 3 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Visual acuity reduced | 2 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Retinal haemorrhage | 4 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Uveitis | 0 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Conjunctivitis | 4 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Dry eye | 3 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Cataract | 8 Participants |
| Aflibercept 2 mg | Most Common Ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) by Preferred Term for the Study Eye | Meibomian gland dysfunction | 7 Participants |
Secondary
Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject. Treatment-emergent AEs are counted, which are AEs that developed on or after first study treatment administration, or any event previously present that worsened following exposure to the study treatment.
Time frame: Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 6 mg | Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) | 97 Participants |
| Aflibercept 2 mg | Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) | 113 Participants |
Secondary
Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48
Time frame: Between Weeks 36 and Weeks 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 1 visit with no fluid between Week 36 to 48 | 13 Participants |
| Brolucizumab 6 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 3 visits with no fluid between Week 36 to 48 | 16 Participants |
| Brolucizumab 6 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 2 visits with no fluid between Week 36 to 48 | 15 Participants |
| Brolucizumab 6 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 4 visits with no fluid between Week 36 to 48 | 137 Participants |
| Brolucizumab 6 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 0 visits with no fluid between Week 36 to 48 | 18 Participants |
| Aflibercept 2 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 4 visits with no fluid between Week 36 to 48 | 127 Participants |
| Aflibercept 2 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 0 visits with no fluid between Week 36 to 48 | 24 Participants |
| Aflibercept 2 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 1 visit with no fluid between Week 36 to 48 | 12 Participants |
| Aflibercept 2 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 2 visits with no fluid between Week 36 to 48 | 18 Participants |
| Aflibercept 2 mg | Number of Participants With Absence of Subretinal Field (SRF) and Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye Between Week 36 and Week 48 | 3 visits with no fluid between Week 36 to 48 | 17 Participants |
Secondary
Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48)
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 4 | 78 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 8 | 32 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 12 | 33 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 16 | 41 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 20 | 55 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 24 | 39 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 28 | 44 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 32 | 55 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 36 | 37 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 40 | 40 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 44 | 45 Participants |
| Brolucizumab 6 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 48 | 35 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 44 | 37 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 4 | 92 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 28 | 40 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 8 | 51 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 40 | 56 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 12 | 44 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 32 | 57 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 16 | 63 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 48 | 52 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 20 | 37 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 36 | 40 Participants |
| Aflibercept 2 mg | Number of Participants With Presence of Subretinal Field (SRF) and/or Intraretinal Fluid (Central Subfield) (IRF) in the Study Eye at Each Postbaseline Visit (and Specifically Week 16 and Week 48) | Week 24 | 63 Participants |
Secondary
Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit
For both arms, the treatment was initiated with 3 monthly injections at Weeks 0, 4 and 8 (loading phase). Week 12 was scheduled as a no injection visit for both arms per protocol. Therefore, by Week 16, the planned treatment exposure was identical between the treatment arms, allowing a matched comparison of brolucizumab and aflibercept up to 8 weeks after loading.
Time frame: Week 16
Population: Full Analysis Set (FAS) - for participants with a valid measurement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brolucizumab 6 mg | Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit | 30 Participants |
| Aflibercept 2 mg | Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit | 47 Participants |
Secondary
Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit
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 between 78 and 23 ETDRS letters (inclusive) at Screening and Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Time frame: Baseline up to Week 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 4 | 36 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 8 | 47 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 12 | 59 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 16 | 69 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 20 | 68 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 24 | 68 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 28 | 73 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 32 | 73 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 36 | 71 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 40 | 73 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 44 | 78 Participants |
| Brolucizumab 6 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 48 | 72 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 44 | 92 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 4 | 50 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 28 | 82 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 8 | 60 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 40 | 84 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 12 | 70 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 32 | 85 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 16 | 74 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 48 | 86 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 20 | 86 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 36 | 87 Participants |
| Aflibercept 2 mg | Number of Subjects With Best-Corrected Visual Acuity of 73 Letters or More at Each Visit | Week 24 | 78 Participants |
Secondary
Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit
As assessed by color fundus photography.
Time frame: Baseline, Week 12, Week 48
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Baseline | 0 Participants |
| Brolucizumab 6 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Week 12 (n=182, 177) | 15 Participants |
| Brolucizumab 6 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Week 48 (n=166,164) | 18 Participants |
| Aflibercept 2 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Baseline | 0 Participants |
| Aflibercept 2 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Week 12 (n=182, 177) | 17 Participants |
| Aflibercept 2 mg | Number of Subjects With Presence of Fibrosis (Central Subfield) in the Study Eye by Visit | Week 48 (n=166,164) | 24 Participants |
Secondary
Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects
The AUC from time zero to infinity (mass x time x volume-1)
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: AUCinf After First Brolucizumab 6 mg Dose in a Subset of Subjects | 3100 h*ng/mL | Geometric Coefficient of Variation 73.4 |
Secondary
Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects
The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: AUClast After First Brolucizumab 6 mg Dose in a Subset of Subjects | 2690 h*ng/mL | Geometric Coefficient of Variation 74.4 |
Secondary
Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects
Apparent total body clearance of siremadlin from serum (CL/F)
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of treated participants
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: CL/F After First Brolucizumab 6 mg Dose in a Subset of Subjects | 1.93 Liters/hour | Geometric Coefficient of Variation 73.4 |
Secondary
Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects
The maximum (peak) observed serum drug concentration after single dose administration (mass x volume-1)
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of participants with a valid measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: Cmax After First Brolucizumab 6 mg Dose in a Subset of Subjects | 39.7 ng/mL | Geometric Coefficient of Variation 121 |
Secondary
Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects
The elimination half-life associated with the terminal slope (lz) of a semi logarithmic concentration time curve (time).
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: T1/2 After First Brolucizumab 6 mg Dose in a Subset of Subjects | 110 hours | Geometric Coefficient of Variation 37.9 |
Secondary
Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects
The time to reach maximum (peak) serum drug concentration after single dose administration (time). Actual sampling times were taken into consideration for the pharmacokinetic (PK) analysis.
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of participants with a valid measurement
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: Tmax After First Brolucizumab 6 mg Dose in a Subset of Subjects | 5.25 hour |
Secondary
Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects
Apparent volume of distribution during terminal elimination phase (Vz/F)
Time frame: Day 1, Day 2, Day 8, Day 15, Day 22, and Day 29
Population: Safety Analysis Set - for a subset of treated participants with a valid measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brolucizumab 6 mg | Pharmacokinetic Parameters: Vz/F After First Brolucizumab 6 mg Dose in a Subset of Subjects | 307 L | Geometric Coefficient of Variation 48.6 |
Secondary
q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability
The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event first q8w-need, applying a q8w-need allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis. The proportion of participants with a positive q12w treatment status was derived as follows according to the sufficient efficacy and safety approach: the q8w-need assessment was imputed as Yes at the disease activity assessment (DAA) visit following early treatment/study discontinuation due to lack of efficacy and /or lack of safety of the study treatment (applicable to both missing and non-missing DAAs).
Time frame: Week 44
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability | 0.595 Probability of no q8w-need |
Secondary
q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability
The estimate for the proportion of participants with a positive q12w treatment status was derived from Kaplan-Meier time-to-event analyses for the event first q8w-need, applying a q8w-need allocation in case of missing or confounded data attributable to lack of efficacy and/or lack of safety for the purpose of analysis. The analysis of q12w treatment status within the participants randomized to brolucizumab 6 mg and with no q8w need during the first q12w cycle was based on the subset of FAS participants randomized to brolucizumab 6 mg with no identified q8w-need at Week 16 and Week 20.
Time frame: Week 44
Population: FAS - Participants in the FAS randomized to brolucizumab 6 mg with no identified q8w-need at Week 16 and Week 20.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brolucizumab 6 mg | q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability | 0.860 Probability of no q8w-need |
Secondary
Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 8 | 19 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 28 | 29 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 16 | 30 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 32 | 34 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 4 | 63 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 36 | 21 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 20 | 35 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 40 | 24 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 12 | 18 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 44 | 27 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 24 | 26 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 48 | 20 Participants |
| Brolucizumab 6 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Baseline | 149 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 48 | 43 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Baseline | 156 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 4 | 83 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 8 | 42 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 12 | 34 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 16 | 50 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 20 | 28 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 24 | 49 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 28 | 31 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 32 | 46 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 36 | 35 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 40 | 49 Participants |
| Aflibercept 2 mg | Subretinal Fluid (SRF) Status in the Central Subfield: Number of Subjects With Presence of SRF by Visit for the Study Eye | Week 44 | 32 Participants |
Secondary
Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Population: Full Analysis Set (FAS) Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 8 | 7 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 28 | 6 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 16 | 12 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 32 | 5 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 4 | 11 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 36 | 8 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 20 | 9 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 40 | 6 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 12 | 10 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 44 | 5 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 24 | 10 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 48 | 6 Participants |
| Brolucizumab 6 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Baseline | 26 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 48 | 9 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Baseline | 32 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 4 | 20 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 8 | 17 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 12 | 13 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 16 | 15 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 20 | 9 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 24 | 10 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 28 | 7 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 32 | 10 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 36 | 7 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 40 | 10 Participants |
| Aflibercept 2 mg | Subretinal Pigment Epithelium (Sub-RPE) Fluid Status in the Central Subfield: Number of Subjects With Presence of Sub-RPE by Visit for the Study Eye | Week 44 | 8 Participants |
Post Hoc
All Collected Deaths
On-treatment deaths are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 48 weeks. Post-treatment deaths are reported 30 days after last treatment to 72 days post treatment (Day 185).
Time frame: Deaths are reported from first dose of study treatment until approximately Day 185.
Population: Safety Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brolucizumab 6 mg | All Collected Deaths | Total Deaths | 0 Participants |
| Brolucizumab 6 mg | All Collected Deaths | On-treatment Deaths | 0 Participants |
| Brolucizumab 6 mg | All Collected Deaths | Post-treatment Deaths | 0 Participants |
| Aflibercept 2 mg | All Collected Deaths | Post-treatment Deaths | 1 Participants |
| Aflibercept 2 mg | All Collected Deaths | On-treatment Deaths | 0 Participants |
| Aflibercept 2 mg | All Collected Deaths | Total Deaths | 1 Participants |