Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
RVO, Kodiak, KSI-301, Vascular endothelial growth factor, Anti-VEGF, VEGF, Antibody biopolymer conjugate, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Aflibercept, Eylea
Brief summary
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
Detailed description
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch or central type). The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.
Interventions
DRUGKSI-301
Intravitreal Injection
DRUGAflibercept
Intravitreal Injection
OTHERSham Procedure
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Sponsors
Kodiak Sciences Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.
Intervention model description
Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept. Participants in the Extension Phase will be treated with KSI-301.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent prior to participation in the study. 2. Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO. 3. BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye. 4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center 5. Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO. 6. Other protocol-specified inclusion criteria may apply.
Exclusion criteria
1. Macular edema in the Study Eye for reasons other than RVO 2. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye. 3. Uncontrolled glaucoma in the Study Eye. 4. Active retinal disease other than the condition under investigation in the Study Eye. 5. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study 6. Active or suspected ocular or periocular infection or inflammation 7. Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation). 8. Women who are pregnant or lactating or intending to become pregnant during the study. 9. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest 10. Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. 11. History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. 12. Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | Day 1 to Week 24 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | Day 1 to Week 24 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Day 1 - Week 48 | Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Day 1 - Week 48. | Percentage of participants with BCVA Snellen Equivalent of 20/40 or Better from Baseline to Week 48. Snellen Equivalent of 20/40 is 69 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Baseline - Week 48 | Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse from Baseline to Week 48. Snellen Equivalent of 20/200 is 38 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N. |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
| Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Mean change in OCT central subfield retinal thickness (CST) from baseline by visit over time (up to Week 48) for all RVO participants. |
| Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Mean change in OCT center point retinal thickness (CPT) from baseline by visit over time (up to Week 48) for all RVO participants. |
| Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Baseline - Week 48 | Macular Edema (ME) is assessed by optical coherence tomography (OCT) central subfield thickness (CST). A thickness of less than 325 microns is considered absence of ME. Proportion of participants with Absence of Macular Edema from Baseline to Week 48. Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
| Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
Countries
Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Poland, Puerto Rico, Slovakia, Spain, United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at 138 medical centers between September 2020 and December 2021. The first participant was enrolled on 25 September 2020 and the last on 15 December 2021.
Pre-assignment details
Of 752 enrolled participants, 568 met eligibility criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| KSI-301 (Arm A) Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44.
In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria.
KSI-301: Intravitreal Injection
Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 284 |
| Aflibercept (Arm B) Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44.
In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria.
Aflibercept: Intravitreal Injection
Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. | 284 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Open-Label Extension Period | Adverse Event | 1 | 2 |
| Open-Label Extension Period | Lost to Follow-up | 1 | 5 |
| Open-Label Extension Period | Non-compliance with Study Schedule | 1 | 0 |
| Open-Label Extension Period | Sponsor Request | 73 | 84 |
| Open-Label Extension Period | Withdrawal by Subject | 5 | 7 |
| Primary Study (Through Year 1) | Adverse Event | 10 | 3 |
| Primary Study (Through Year 1) | Lost to Follow-up | 5 | 5 |
| Primary Study (Through Year 1) | Non-compliance with Study Schedule | 0 | 1 |
| Primary Study (Through Year 1) | Participant left the country | 2 | 0 |
| Primary Study (Through Year 1) | Participant moved to another city with no available site | 0 | 1 |
| Primary Study (Through Year 1) | Progressive Disease | 1 | 1 |
| Primary Study (Through Year 1) | Sponsor Request | 4 | 5 |
| Primary Study (Through Year 1) | Withdrawal by Subject | 7 | 13 |
Baseline characteristics
| Characteristic | KSI-301 (Arm A) | Aflibercept (Arm B) | Total |
|---|---|---|---|
| Age, Customized 18-64 years | 126 Participants | 142 Participants | 268 Participants |
| Age, Customized 65-74 years | 94 Participants | 86 Participants | 180 Participants |
| Age, Customized 75-84 years | 50 Participants | 41 Participants | 91 Participants |
| Age, Customized ≥ 85 years | 14 Participants | 15 Participants | 29 Participants |
| Blood Pressure at Baseline Diastolic | 82.8 mmHG STANDARD_DEVIATION 8.71 | 82.6 mmHG STANDARD_DEVIATION 9.33 | 82.7 mmHG STANDARD_DEVIATION 9.02 |
| Blood Pressure at Baseline Systolic | 139.1 mmHG STANDARD_DEVIATION 16.66 | 138.7 mmHG STANDARD_DEVIATION 16.42 | 138.9 mmHG STANDARD_DEVIATION 16.52 |
| Geographic Region North America | 193 Participants | 193 Participants | 386 Participants |
| Geographic Region Rest of World | 91 Participants | 91 Participants | 182 Participants |
| Race/Ethnicity, Customized Choose Not to Respond | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 31 Participants | 29 Participants | 60 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 242 Participants | 246 Participants | 488 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 17 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) White | 240 Participants | 245 Participants | 485 Participants |
| Sex: Female, Male Female | 141 Participants | 138 Participants | 279 Participants |
| Sex: Female, Male Male | 143 Participants | 146 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 284 | 1 / 284 | 2 / 444 |
| other Total, other adverse events | 73 / 284 | 66 / 284 | 53 / 444 |
| serious Total, serious adverse events | 36 / 284 | 23 / 284 | 18 / 444 |
Outcome results
Primary
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
Time frame: Day 1 to Week 24
Population: Full Analysis Set (Week 24) includes all randomized subjects who received at least one treatment injection in the first 24 weeks and using all available post baseline measurements up to Week 24 or until the subject discontinues study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| KSI-301 (Arm A) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | 13.0 ETDRS Letters | Standard Error 0.83 |
| Aflibercept (Arm B) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | 15.5 ETDRS Letters | Standard Error 0.81 |
p-value: 0.024395.02% CI: [-4.24, -0.71]Mixed Models Analysis
Primary
Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
Time frame: Day 1 to Week 24
Population: Full Analysis Set (Week 24) includes all randomized participants who received at least one treatment injection in the first 24 weeks and using all available post baseline measurements up to Week 24 or until the participant discontinues study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| KSI-301 (Arm A) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | 14.2 ETDRS Letters | Standard Error 0.81 |
| Aflibercept (Arm B) | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | 15.6 ETDRS Letters | Standard Error 0.79 |
p-value: 0.000495.02% CI: [-3.11, 0.3]Mixed Models Analysis
Secondary
Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants.
BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.
Time frame: Day 1 - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 8 | 11.4 ETDRS Letters | Standard Deviation 10.38 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 28 | 12.8 ETDRS Letters | Standard Deviation 11.85 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 16 | 12.7 ETDRS Letters | Standard Deviation 11.99 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 32 | 13.3 ETDRS Letters | Standard Deviation 11.55 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 4 | 8.9 ETDRS Letters | Standard Deviation 9.89 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 36 | 13.1 ETDRS Letters | Standard Deviation 11.52 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 20 | 12.4 ETDRS Letters | Standard Deviation 12.29 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 40 | 13.9 ETDRS Letters | Standard Deviation 11.51 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 12 | 10.0 ETDRS Letters | Standard Deviation 12.58 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 44 | 13.6 ETDRS Letters | Standard Deviation 11.26 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 24 | 14.0 ETDRS Letters | Standard Deviation 11.42 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 48 | 13.5 ETDRS Letters | Standard Deviation 12.1 |
| KSI-301 (Arm A) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 1 | 7.7 ETDRS Letters | Standard Deviation 9.25 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 48 | 14.2 ETDRS Letters | Standard Deviation 13.64 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 1 | 7.9 ETDRS Letters | Standard Deviation 7.74 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 4 | 11.2 ETDRS Letters | Standard Deviation 10.01 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 8 | 13.5 ETDRS Letters | Standard Deviation 9.78 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 12 | 14.2 ETDRS Letters | Standard Deviation 10.05 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 16 | 14.9 ETDRS Letters | Standard Deviation 10.52 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 20 | 15.3 ETDRS Letters | Standard Deviation 11.86 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 24 | 15.6 ETDRS Letters | Standard Deviation 11.54 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 28 | 14.1 ETDRS Letters | Standard Deviation 12.9 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 32 | 13.8 ETDRS Letters | Standard Deviation 12.46 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 36 | 13.5 ETDRS Letters | Standard Deviation 11.96 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 40 | 13.9 ETDRS Letters | Standard Deviation 12.87 |
| Aflibercept (Arm B) | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Week 44 | 13.7 ETDRS Letters | Standard Deviation 13.11 |
Secondary
Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants.
Mean change in OCT center point retinal thickness (CPT) from baseline by visit over time (up to Week 48) for all RVO participants.
Time frame: Day 1 - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 36 | -286.8 micrometers (um) | Standard Deviation 229.63 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 16 | -311.5 micrometers (um) | Standard Deviation 237.01 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 4 | -278.5 micrometers (um) | Standard Deviation 212.92 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 20 | -258.1 micrometers (um) | Standard Deviation 236.58 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 32 | -288.9 micrometers (um) | Standard Deviation 229.6 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 24 | -327.9 micrometers (um) | Standard Deviation 223.13 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 8 | -301.4 micrometers (um) | Standard Deviation 220.72 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 28 | -280.5 micrometers (um) | Standard Deviation 232.22 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 40 | -290.7 micrometers (um) | Standard Deviation 220.56 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 1 | -278.7 micrometers (um) | Standard Deviation 186.23 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 44 | -281.5 micrometers (um) | Standard Deviation 221.38 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 12 | -230.3 micrometers (um) | Standard Deviation 248.92 |
| KSI-301 (Arm A) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 48 | -279.6 micrometers (um) | Standard Deviation 231.43 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 48 | -331.6 micrometers (um) | Standard Deviation 259.43 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 28 | -328.0 micrometers (um) | Standard Deviation 249.96 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 32 | -322.4 micrometers (um) | Standard Deviation 244.98 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 36 | -308.1 micrometers (um) | Standard Deviation 247.22 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 1 | -320.9 micrometers (um) | Standard Deviation 200 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 4 | -358.4 micrometers (um) | Standard Deviation 224.51 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 8 | -373.9 micrometers (um) | Standard Deviation 235.35 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 12 | -377.6 micrometers (um) | Standard Deviation 239.01 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 16 | -381.3 micrometers (um) | Standard Deviation 240.74 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 20 | -385.4 micrometers (um) | Standard Deviation 238.61 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 24 | -387.5 micrometers (um) | Standard Deviation 240.42 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 40 | -328.7 micrometers (um) | Standard Deviation 261.26 |
| Aflibercept (Arm B) | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Week 44 | -306.6 micrometers (um) | Standard Deviation 252.79 |
Secondary
Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants.
Mean change in OCT central subfield retinal thickness (CST) from baseline by visit over time (up to Week 48) for all RVO participants.
Time frame: Day 1 - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 8 | -255.6 micrometers (um) | Standard Deviation 190.4 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 28 | -240.4 micrometers (um) | Standard Deviation 200.78 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 16 | -264.9 micrometers (um) | Standard Deviation 204.77 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 32 | -246.6 micrometers (um) | Standard Deviation 200.99 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 4 | -230.8 micrometers (um) | Standard Deviation 181.37 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 36 | -243.4 micrometers (um) | Standard Deviation 198.13 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 20 | -218.1 micrometers (um) | Standard Deviation 203.88 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 40 | -246.9 micrometers (um) | Standard Deviation 193.79 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 12 | -195.8 micrometers (um) | Standard Deviation 213.7 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 44 | -237.5 micrometers (um) | Standard Deviation 189.3 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 24 | -278.9 micrometers (um) | Standard Deviation 192.68 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 48 | -240.0 micrometers (um) | Standard Deviation 203.97 |
| KSI-301 (Arm A) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 1 | -225.2 micrometers (um) | Standard Deviation 152.87 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 48 | -278.8 micrometers (um) | Standard Deviation 224.13 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 1 | -255.9 micrometers (um) | Standard Deviation 168.25 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 4 | -294.2 micrometers (um) | Standard Deviation 195.07 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 8 | -310.1 micrometers (um) | Standard Deviation 203.17 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 12 | -314.8 micrometers (um) | Standard Deviation 208.68 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 16 | -321.0 micrometers (um) | Standard Deviation 209.84 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 20 | -323.0 micrometers (um) | Standard Deviation 209.89 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 24 | -326.6 micrometers (um) | Standard Deviation 210.78 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 28 | -273.9 micrometers (um) | Standard Deviation 218.56 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 32 | -269.7 micrometers (um) | Standard Deviation 213.89 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 36 | -258.6 micrometers (um) | Standard Deviation 213.44 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 40 | -274.9 micrometers (um) | Standard Deviation 229.38 |
| Aflibercept (Arm B) | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Week 44 | -258.3 micrometers (um) | Standard Deviation 216.49 |
Secondary
Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants.
Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N.
Time frame: Day 1 - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 1. | 176 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 36. | 158 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 4. | 197 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 16. | 109 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 8. | 211 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 48. | 159 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 12. | 198 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 20. | 109 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 16. | 222 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 32. | 164 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 20. | 199 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 24. | 121 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 24. | 215 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 1. | 46 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 28. | 206 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 28. | 111 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 32. | 200 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 40. | 167 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 36. | 205 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 32. | 113 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 40. | 210 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 4. | 69 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 44. | 196 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 36. | 108 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 48. | 199 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 28. | 160 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 1. | 94 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 40. | 107 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 4. | 120 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 8. | 92 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 8. | 151 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 44. | 111 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 12. | 141 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 44. | 156 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 16. | 168 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 48. | 112 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 20. | 168 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 12. | 83 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 24. | 177 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 16. | 240 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 28. | 168 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 32. | 172 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 36. | 162 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 40. | 162 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 44. | 164 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 48. | 164 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 1. | 49 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 4. | 85 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 8. | 111 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 12. | 119 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 16. | 131 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 20. | 137 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 24. | 138 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 28. | 118 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 32. | 113 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 36. | 112 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 40. | 120 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 44. | 116 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 15 letters from baseline to Week 48. | 120 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 1. | 176 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 4. | 202 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 8. | 233 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 12. | 237 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 24. | 188 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 20. | 235 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 24. | 233 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 28. | 211 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 32. | 213 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 36. | 212 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 40. | 215 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 44. | 211 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 5 letters from baseline to Week 48. | 206 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 1. | 91 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 4. | 145 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 8. | 175 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 12. | 179 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 16. | 181 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Participants who gain ≥ 10 letters from baseline to Week 20. | 183 Participants |
Secondary
Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants
Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N.
Time frame: Day 1 - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 1. | 5 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 4. | 19 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 8. | 14 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 12. | 18 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 16. | 13 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 20. | 17 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 24. | 13 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 28. | 16 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 32. | 14 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 36. | 16 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 40. | 13 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 44. | 10 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 48. | 18 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 1. | 3 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 4. | 4 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 8. | 6 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 12. | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 16. | 6 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 20. | 10 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 24. | 4 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 28. | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 32. | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 36. | 10 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 40. | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 44. | 6 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 48. | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 1. | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 4. | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participant who lose ≥ 15 letters from baseline to Week 8. | 1 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 12. | 6 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 16. | 5 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 20. | 4 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 24. | 1 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 28. | 5 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 32. | 4 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 36. | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 40. | 3 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 44. | 3 Participants |
| KSI-301 (Arm A) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 48. | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 24. | 4 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 1. | 6 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 12. | 0 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 4. | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 28. | 8 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 8. | 3 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 32. | 6 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 12. | 3 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 32. | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 16. | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 16. | 1 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 20. | 8 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 36. | 4 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 24. | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 48. | 8 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 28. | 10 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 40. | 8 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 32. | 9 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 20. | 2 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 36. | 11 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 44. | 9 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 40. | 14 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 36. | 2 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 44. | 15 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 48. | 9 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 5 letters from baseline to Week 48. | 15 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 24. | 2 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 1. | 1 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 1. | 0 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 4. | 1 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 44. | 6 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 8. | 1 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 4. | 1 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 12. | 0 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 28. | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 16. | 2 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participant who lose ≥ 15 letters from baseline to Week 8. | 0 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 10 letters from baseline to Week 20. | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Participants who lose ≥ 15 letters from baseline to Week 40. | 5 Participants |
Secondary
Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants.
Macular Edema (ME) is assessed by optical coherence tomography (OCT) central subfield thickness (CST). A thickness of less than 325 microns is considered absence of ME. Proportion of participants with Absence of Macular Edema from Baseline to Week 48. Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N.
Time frame: Baseline - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Baseline | 4 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 1 | 156 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 4 | 174 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 8 | 205 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 12 | 160 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 16 | 218 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 20 | 174 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 24 | 221 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 28 | 185 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 32 | 168 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 36 | 172 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 40 | 179 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 44 | 160 Participants |
| KSI-301 (Arm A) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 48 | 166 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 36 | 172 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Baseline | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 24 | 247 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 1 | 150 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 44 | 177 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 4 | 225 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 28 | 196 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 8 | 247 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 40 | 188 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 12 | 252 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 32 | 173 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 16 | 245 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 48 | 187 Participants |
| Aflibercept (Arm B) | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Absence of Macular Edema at Week 20 | 240 Participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants.
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse from Baseline to Week 48. Snellen Equivalent of 20/200 is 38 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N.
Time frame: Baseline - Week 48
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Baseline | 22 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 1 | 9 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 4 | 10 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 8 | 6 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 12 | 11 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 16 | 7 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 20 | 7 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 24 | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 28 | 5 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 32 | 3 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 36 | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 40 | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 44 | 2 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 48 | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 36 | 3 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Baseline | 31 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 24 | 4 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 1 | 12 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 44 | 6 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 4 | 9 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 28 | 6 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 8 | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 40 | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 12 | 4 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 32 | 5 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 16 | 7 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 48 | 8 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Snellen Equivalent of 20/200 or Worse at Week 20 | 5 Participants |
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants.
Percentage of participants with BCVA Snellen Equivalent of 20/40 or Better from Baseline to Week 48. Snellen Equivalent of 20/40 is 69 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N.
Time frame: Day 1 - Week 48.
Population: Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Baseline. | 92 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 1. | 168 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 4. | 173 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 8. | 185 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 12. | 186 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 16. | 200 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 20. | 189 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 24. | 196 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 28. | 192 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 32. | 182 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 36. | 188 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 40. | 191 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 44. | 184 Participants |
| KSI-301 (Arm A) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 48. | 182 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 36. | 192 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Baseline. | 90 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 24. | 205 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 1. | 153 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 44. | 191 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 4. | 182 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 28. | 197 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 8. | 198 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 40. | 193 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 12. | 199 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 32. | 190 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 16. | 209 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 48. | 190 Participants |
| Aflibercept (Arm B) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Snellen equivalent of 20/40 or better at Week 20. | 207 Participants |