This clinical trial is focused on studying Diabetic Macular Edema (DME), a condition that affects the eyes of people with diabetes, leading to vision problems. The study will test the effectiveness and safety of a new treatment called OCS-01, which is an eye drop containing the active ingredient dexamethasone. Dexamethasone is a type of medication known as a corticosteroid, which is used to reduce inflammation and swelling.
The purpose of the study is to compare the effects of OCS-01 with a placebo over a period of 52 weeks. Participants will be randomly assigned to receive either the OCS-01 eye drops or a placebo. Throughout the study, participants will have regular check-ups to monitor their eye health and overall well-being. The main goal is to see if there is an improvement in vision, specifically looking at changes in the ability to see clearly, which is measured by a test called Best Corrected Visual Acuity (BCVA).
Participants will also be monitored for any side effects or changes in their eye condition. The study aims to provide valuable information on whether OCS-01 can be a safe and effective treatment option for people with Diabetic Macular Edema. This research could potentially lead to better management of this eye condition, improving the quality of life for those affected by it.



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