|Condition or Disease||Intervention / Treatment||Phase||Sponsor||Status|
|Nonproliferative Diabetic Retinopathy|
|3||Kodiak Science Inc.||Enrolling|
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). Participants will be randomized 1:1 into one of two arms: KSI-301 or sham. To preserve masking (or the study blind), two investigators are required for this study. The masked (blinded) investigator will be responsible for examinations and safety assessments. The unmasked (unblinded) investigator will perform the study drug injections and post-treatment assessments. 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.