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NCT05608837 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
A Phase 2 study of Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative, sponsored by Quan Dong Nguyen.
- Active
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 8
- Study locations
NCT05608837: Active Phase 2 study of Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative, sponsored by Quan Dong Nguyen.
NCT05608837 is a Phase 2 study of Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative that is active but no longer recruiting, run by Quan Dong Nguyen. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608837, a Phase 2 study of Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative, is active but no longer recruiting, sponsored by Quan Dong Nguyen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline.
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 |
What the registry record for NCT05608837 still lists
NCT05608837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
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.
NCT05608837 lists 8 locations in 4 states (California, Texas, Massachusetts).
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.
What interventions are being tested in trial NCT05608837?
The interventions under investigation include: OCS-01 (DRUG).
Who is sponsoring clinical trial NCT05608837?
This trial is sponsored by Quan Dong Nguyen, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05608837's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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