A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

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).

Key facts

Study ID

NCT05066997

Run by

Oculis

People needed

552

Starts

2021-10-19

Expected to finish

2026-04-10

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Phoenix Retina Associates — Phoenix, Arizona, United States
• Retina Partners of Northwest Arkansas — Springdale, Arkansas, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• The Retina Partners — Encino, California, United States
• Retinal Consultants Medical Group — Modesto, California, United States
• California Eye Specialists Medical Group — Pasadena, California, United States
• California Eye Specialists Medical Group — Redlands, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• California Retina Consultants — Santa Maria, California, United States
• Retina Group Of New England — Waterford, Connecticut, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Florida Retina Institute — Jacksonville, Florida, United States
• MedEye Associates — Miami, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Retina Associates — Elmhurst, Illinois, United States
• University Retina — Lemont, Illinois, United States
• Midwest Eye Institute — Carmel, Indiana, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Retina Consultants of Minnesota — Saint Louis Park, Minnesota, United States
• The Retina Institute — St Louis, Missouri, United States
• Retina-Vitreous Surgeons of Central New York — Liverpool, New York, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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