Overview
The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).
Description
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema
Eligibility
Inclusion Criteria (selection):
- Have a signed informed consent form before any study-specific procedures are performed.
- Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
- Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1).
Exclusion Criteria (selection):
- Have macular edema considered to be because of a cause other than DME.
- Have a decrease in BCVA because of causes other than DME.
- Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.