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