Uveitis Related Cystoid Macular Edema Clinical Trial
Official title:
Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (The LEOPARD Study)
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.
LEOPARD is a prospective, multi-center, single masked, randomized, controlled, study. At least 24 eligible subjects (12 with Uveitic macular edema and 12 with Post surgical macular edema) are to be enrolled in the study. There will be 5 sites and the total treatment period is 24 weeks. The study will consist of 4 phases: Screening Phase, Loading Phase, Treatment Phase and Follow-up Phase. Subjects will receive their assigned treatments until week 04, get randomized into groups and continue their assigned treatments until week 12. Primary endpoint assessments will be performed at week 12. From week 12 to week 24, if there is still edema as demonstrated on OCT, subjects will receive treatment based on the retreatment criteria. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01564108 -
The LIMO Study, Lucentis for Treatment of Uveitic Patients With Refractory Cystoid Macular Oedema
|
Phase 2 | |
| Completed |
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Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
|
N/A |