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

NCT05608837 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-05-25

No results posted yet for this 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

  • Uveitis Related Cystoid Macular Edema
  • Cystoid Macular Edema, Postoperative

Interventions

DRUG

OCS-01

One drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.

Sponsors & Collaborators

  • Global Ophthalmic Research Center (GORC)

    collaborator UNKNOWN

  • Oculis

    collaborator INDUSTRY

  • Quan Dong Nguyen

    lead OTHER

Principal Investigators

  • Quan D Nguyen, MD, MSc · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608837 on ClinicalTrials.gov