Active — Not RecruitingPhase 2

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

United States28 participantsStarted 2023-05-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 years or older.
✓. Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME).
✓. Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits.
✓. UME of less than 1 years in duration or PSME of less than 1 year, with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥ 320 µm by SD-OCT at baseline (as measured by the central reading center employing Heidelberg Spectralis spectral domain optical coherence tomography, SD-OCT). Note: Recurrent CME is also eligible if the current episode is of less than 1 year.
✓. An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2).
✓. A documented diagnosis of inactive/stable uveitis (for UME) at the screening visit.
✓. A trial of topical NSAID or topical corticosteroids (for PSME) for at least one consecutive month but less than 3 consecutive months before screening visit with documented treatment failure on SD-OCT or based on investigator's clinical evaluation.

Exclusion criteria

What they're measuring

Central Subfield Thickness

Timeframe: Baseline to 12 weeks

Visual Acuity

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT05608837

SponsorQuan Dong Nguyen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Uveitis Related Cystoid Macular Edema trials