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A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Pa… (NCT04603937) | Clinical Trial Compass
Phase 3
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Stopped: Study did not meet primary endpoint
Plain-language summary This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
Who can participate See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓ . Signed informed consent prior to participation in the study. ✓ . Treatment-naïve diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening. ✓ . BCVA ETDRS letter score between 78 and 25 (-20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye. ✓ . CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center. ✓ . Decrease in vision determined by the Investigator to be primarily the result of DME. ✓ . Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%. ✓ . Other protocol-specified inclusion criteria may apply. ✕ . Macular edema in the Study Eye considered to be secondary to a cause other than DME. ✕ . Active iris or angle neovascularization or neovascular glaucoma in the Study Eye. ✕ . High-risk proliferative diabetic retinopathy characteristics in the Study Eye. ✕ . History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening. ✕ . Tractional retinal detachment in the Study Eye. What they're measuring 1 Mean Change in BCVA
Timeframe: Day 1 to Week 64
Trial details NCT ID NCT04603937
Sponsor Kodiak Sciences Inc
Sponsor type INDUSTRY
Study type INTERVENTIONAL
Primary completion 2023-04-27
Results submitted 2024-07-25
✕
. Active retinal disease other than the condition under investigation in the Study Eye.
✕ . Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study (e.g., vitreomacular traction, epiretinal membrane).
✕ . Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.