NCT04603937

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

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 Secondary to Treatment-naïve Diabetic Macular Edema (DME)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (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 treatment-naïve DME.

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 treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.

Conditions

• Diabetic Macular Edema

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: 2020-09-30
• Primary completion: 2023-04-27
• Completion: 2023-08-31
• First posted: 2020-10-27
• Last updated: 2024-08-22
• Results posted: 2024-08-22

Locations

72 sites across 8 countries: United States, Czechia, France, Hungary, Israel, Italy, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study