NCT05066230

A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)

A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Kodiak Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Detailed description

This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.

Conditions

• Non-proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	KSI-301	Intravitreal injection
OTHER	Sham injection	The sham injection 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 is performed to maintain masking of the study.

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-08-03
• Completion: 2023-08-31
• First posted: 2021-10-04
• Last updated: 2024-09-05
• Results posted: 2024-09-05

Locations

61 sites across 7 countries: United States, Czechia, Latvia, Poland, Puerto Rico, Slovakia, Spain

Regulatory

• FDA-regulated drug study