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.~This includes an optional open-label, two-arm, double-masked Extension Phase in which participants completing the primary BEACON study are eligible to participate. All participants who enroll into the Extension Phase will be treated with KSI-301 5 mg. The Extension Phase will have the final study assessment at Week 72 for efficacy endpoints and a final safety follow-up at Week 76.
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).