A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
brief summary
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
detailed description
A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema
Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.
Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
official title
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