NCT04592419

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)

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Kodiak Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	KSI-301	Intravitreal Injection
DRUG	Aflibercept	Intravitreal Injection
OTHER	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.

Timeline

• Start date: 2020-09-25
• Primary completion: 2022-06-10
• Completion: 2023-01-19
• First posted: 2020-10-19
• Last updated: 2024-06-26
• Results posted: 2024-06-06

Locations

141 sites across 12 countries: United States, Czechia, France, Germany, Hungary, Israel, Italy, Latvia, Poland, Puerto Rico, Slovakia, Spain

Regulatory

• FDA-regulated drug study