Central Retinal Vein Occlusion
Conditions
Keywords
Bayer, Aflibercept, Eylea, Intravitreal
Brief summary
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries. The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.
Interventions
The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit). * Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T&E regimen after initial dosing. * Treatment-naïve subjects for macular edema secondary to CRVO. * Men and women ≥ 18 years of age. * Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.
Exclusion criteria
* Previous PRP or macular laser photocoagulation in the study eye. * Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded. * Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study. * Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1. * Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening. * Any history of allergy to povidone iodine. * Known serious allergy to the fluorescein sodium for injection in angiography. * Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline | Baseline, Week 24 and Week 76 | Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity. |
| The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks | From the last actual visit of the initiation phase to Week 76 | Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Central Retinal Thickness (CRT) From Baseline | Baseline and Week 24, 52 and 76 | CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT). |
| The Number of Injections Per Participant | From baseline to Week 76 | — |
| The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline | Baseline and Week 24, Week 52 | The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity |
| The Mean Treatment Interval Between Injections | From baseline to Week 76 | — |
| The Proportion of Participants With Absence of Subretinal Fluid | Baseline, week 24, week 52 and week 76 | — |
| Incidence and Severity of Ocular Treatment-emergent Adverse Events | Up to 30 days after week 76 | — |
| The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline and Week 24, 52 and 76 | The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, \<10 ischemic disc area, \>=10 ischemic disc area and missing status |
| The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Baseline and Week 24, 52, and 76 | The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity |
Countries
Australia, Canada, Denmark, France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
A total of 244 participants were screened in 42 study centers in 8 countries, the first subject first visit was on 10/Jun/2016 and last subject last visit was on 31/Jun/2019
Pre-assignment details
Of the 244 screened participants, 162 subjects completed screening and entered the treatment period
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal (IVT) Aflibercept Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 10 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Intravitreal (IVT) Aflibercept |
|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 13.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 154 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 162 |
| other Total, other adverse events | 81 / 162 |
| serious Total, serious adverse events | 32 / 162 |
Outcome results
Primary
The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Time frame: Baseline, Week 24 and Week 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment. Last observation carried forward (LOCF) imputation method.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline | 65.6 percent | 95% Confidence Interval 57.7 |
Comparison: The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be truep-value: <0.0001Exact one-sided 1-sample binomial test
Primary
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Time frame: From the last actual visit of the initiation phase to Week 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks | 45.0 percent | 95% Confidence Interval 37.1 |
Comparison: The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be truep-value: =0.8822Exact one-sided 1-sample binomial test
Secondary
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Time frame: Up to 30 days after week 76
Population: Safety analysis set: included all participants who received any study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | Incidence and Severity of Ocular Treatment-emergent Adverse Events | Any ocular TEAEs | 90 Participants |
| Intravitreal (IVT) Aflibercept | Incidence and Severity of Ocular Treatment-emergent Adverse Events | Severity: mild | 39 Participants |
| Intravitreal (IVT) Aflibercept | Incidence and Severity of Ocular Treatment-emergent Adverse Events | Severity: moderate | 43 Participants |
| Intravitreal (IVT) Aflibercept | Incidence and Severity of Ocular Treatment-emergent Adverse Events | Severity: severe | 8 Participants |
Secondary
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Time frame: Baseline and Week 24, 52, and 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Absolute BCVA letter score at baseline | 51.9 scores | Standard Deviation 16.8 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Absolute BCVA letter score at Week 24 | 72.4 scores | Standard Deviation 16.6 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Absolute BCVA letter score at Week 52 | 71.8 scores | Standard Deviation 18.1 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Absolute BCVA letter score at Week 76 | 72.3 scores | Standard Deviation 18.5 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Change from baseline at Week 24 | 20.4 scores | Standard Deviation 17 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Change from baseline at Week 52 | 19.9 scores | Standard Deviation 19.1 |
| Intravitreal (IVT) Aflibercept | The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline | Change from baseline at Week 76 | 20.3 scores | Standard Deviation 19.5 |
Secondary
The Change in Central Retinal Thickness (CRT) From Baseline
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Time frame: Baseline and Week 24, 52 and 76
Population: Included all participants who received any study drug, had a baseline CRT assessment, and had post-baseline CRT assessment at Week 24, 52 and 76
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Absolute CRT at baseline | 759.9 micrometer | Standard Deviation 246 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Absolute CRT at Week 24 | 271.2 micrometer | Standard Deviation 53.1 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Absolute CRT at Week 52 | 279.8 micrometer | Standard Deviation 106.8 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Absolute CRT at Week 76 | 265.4 micrometer | Standard Deviation 57.9 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Change from baseline at Week 24 | -488.9 micrometer | Standard Deviation 254.6 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Change from baseline at Week 52 | -481.3 micrometer | Standard Deviation 266.5 |
| Intravitreal (IVT) Aflibercept | The Change in Central Retinal Thickness (CRT) From Baseline | Change from baseline at Week 76 | -496.1 micrometer | Standard Deviation 252.4 |
Secondary
The Mean Treatment Interval Between Injections
Time frame: From baseline to Week 76
Population: Participants in full analysis set (received any study drug, had a baseline BCVA assessment and at least one post-baseline BCVA assessment) that completed study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Mean Treatment Interval Between Injections | 6.37 weeks | Standard Deviation 1.15 |
Secondary
The Number of Injections Per Participant
Time frame: From baseline to Week 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Number of Injections Per Participant | 12.2 injections | Standard Deviation 2.53 |
Secondary
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Time frame: Baseline and Week 24, Week 52
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline | Week 24 | 68.8 percent | 95% Confidence Interval 61 |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline | Week 52 | 68.1 percent | 95% Confidence Interval 60.3 |
Secondary
The Proportion of Participants With Absence of Subretinal Fluid
Time frame: Baseline, week 24, week 52 and week 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Absence of Subretinal Fluid | Baseline | 25.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Absence of Subretinal Fluid | Week 24 | 98.7 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Absence of Subretinal Fluid | Week 52 | 95.4 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Absence of Subretinal Fluid | Week 76 | 97.8 percent |
Secondary
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, \<10 ischemic disc area, \>=10 ischemic disc area and missing status
Time frame: Baseline and Week 24, 52 and 76
Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: missing to <10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: missing to >=10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: no to <10 | 4.4 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: no to >=10 | 3.8 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: no to missing | 6.3 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: <10 to no | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: <10 to >=10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: <10 to missing | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: >=10 to no | 1.3 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: >=10 to <10 | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: >=10 to missing | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: missing to no | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: missing to <10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: missing to >=10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 24: no status change | 81.9 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: no to <10 | 5.0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: no to >=10 | 5.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: no to missing | 10.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: <10 to no | 1.9 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: <10 to >=10 | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: <10 to missing | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: >=10 to no | 1.9 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: >=10 to <10 | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: >=10 to missing | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: missing to no | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: missing to <10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: missing to >=10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 52: no status change | 73.8 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: no to <10 | 3.1 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: no to >=10 | 4.4 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: no to missing | 18.1 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: <10 to no | 1.3 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: <10 to >=10 | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: <10 to missing | 0.6 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: >=10 to no | 0.3 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: >=10 to <10 | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: missing to no | 0 percent |
| Intravitreal (IVT) Aflibercept | The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline | Baseline to week 76: no status change | 69.4 percent |