A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Fecha de inicio: 19 de octubre de 2021

Inclusion Criteria (selection) - Stage 1: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening). Inclusion Criteria (selection) - Stage 2: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening). Exclusion criteria (selection) - Stage 1 and Stage 2: 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.