Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
NCT05608837 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG OCS-01
Study Locations (8)
California
- Retina Vitreous Associates Medical Group — Beverly Hills
- Retina Associates of Southern California — Huntington Beach
- Stein Eye Institute at UCLA — Los Angeles
- Byers Eye Institute at Stanford — Palo Alto
Texas
- Valley Retina Institute P.A — McAllen
- Texas Retina Associates — Plano
Massachusetts
- Massachusetts Eye Research and Surgery Institution — Boston
Pennsylvania
- Erie Retina Research — Erie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2023-05-26 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608837
The ClinicalTrials.gov registry entry for NCT05608837 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quan Dong Nguyen, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Uveitis Related Cystoid Macular Edema appearing as the primary indexed condition, and to 1 intervention — of which OCS-01 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05608837 reports 8 study locations spanning 4 distinct geographic areas — top geographies include California, Texas, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05608837 about?
NCT05608837 is a clinical study titled "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...
What is the current status of trial NCT05608837?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2023-05-26. Estimated completion is 2026-09.
What conditions does trial NCT05608837 study?
This clinical trial studies the following conditions: Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05608837?
The interventions under investigation include: OCS-01 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05608837?
This trial is sponsored by Quan Dong Nguyen, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05608837 being conducted?
This trial has 8 study locations across California, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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