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ACTIVE NOT RECRUITING
NCT05608837
PHASE2

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

Sponsor: Quan Dong Nguyen

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (The LEOPARD Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2023-05-26

Completion Date

2026-09

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

DRUG

OCS-01

One drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.

Locations (8)

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

Stein Eye Institute at UCLA

Los Angeles, California, United States

Byers Eye Institute at Stanford

Palo Alto, California, United States

Massachusetts Eye Research and Surgery Institution

Boston, Massachusetts, United States

Erie Retina Research

Erie, Pennsylvania, United States

Valley Retina Institute P.A

McAllen, Texas, United States

Texas Retina Associates

Plano, Texas, United States