Phase 3
N=568
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
Macular Edema · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT04592419 ↗Enrolled (actual)
568
Serious AEs
7.6%
Results posted
Jun 2024
Primary outcome: Primary: Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. — 14.2; 15.6 ETDRS Letters — p=.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KSI-301 (Drug); Aflibercept (Drug); Sham Procedure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kodiak Sciences Inc
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. |
14.2; 15.6 | .0004 sig |
| PRIMARY Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. |
13.0; 15.5 | .0243 sig |
| SECONDARY Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. |
7.7; 7.9; 8.9; 11.2; 11.4; 13.5 | — |
| SECONDARY Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. |
176; 176; 197; 202; 211; 233 | — |
| SECONDARY Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants |
5; 6; 19; 7; 14; 3 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. |
92; 90; 168; 153; 173; 182 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. |
22; 31; 9; 12; 10; 9 | — |
| SECONDARY Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. |
4; 7; 156; 150; 174; 225 | — |
| SECONDARY Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. |
-225.2; -255.9; -230.8; -294.2; -255.6; -310.1 | — |
| SECONDARY Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. |
-278.7; -320.9; -278.5; -358.4; -301.4; -373.9 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to participation in the study.
- 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.
- BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
- CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
- Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Macular edema in the Study Eye for reasons other than RVO
- Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
- Uncontrolled glaucoma in the Study Eye.
- Active retinal disease other than the condition under investigation in the Study Eye.
- 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
- Active or suspected ocular or periocular infection or inflammation
- 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).
- Women who are pregnant or lactating or intending to become pregnant during the study.
- Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
- 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.
- 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.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04592419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.