Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01. Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Among other causes, macular edema can happen because of a disease of the eye called Uveitis, and also after eye surgery. Treatment of macular edema remains a challenge as the condition may persist for several months and may lead to irreversible changes in the eye and poor vision. In the LEOPARD study the investigators wish to see how safe is the study drug (OCS-01) and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery. Participants will undergo detailed eye exam, and record their eye and medical history to see what their disease status is and if they can be included in the study based on the study criteria. If included, they will take the study drug OCS-01 in different doses for 24 weeks. During the study period, they will have regular eye exams to ensure their safety and to assess the usefulness of the study drug.

NCT Number	NCT05608837
Lead Sponsor	Quan Dong Nguyen Collaborators: Global Ophthalmic Research Center (GORC), Oculis
Conditions	Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Enrollment	28 participants
Start Date	2023-05-26
Primary Completion	2026-06 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-05-25