๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-20

Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema (NCT05608837)

Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (The LEOPARD Study)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Quan Dong Nguyen

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Retina Vitreous Associates Medical Group โ€” Beverly Hills, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • Retina Vitreous Associates Medical Group โ€” Beverly Hills, California
  • Retina Associates of Southern California โ€” Huntington Beach, California
  • Stein Eye Institute at UCLA โ€” Los Angeles, California
  • Byers Eye Institute at Stanford โ€” Palo Alto, California
  • Massachusetts Eye Research and Surgery Institution โ€” Boston, Massachusetts
  • Erie Retina Research โ€” Erie, Pennsylvania
  • Valley Retina Institute P.A โ€” McAllen, Texas
  • Texas Retina Associates โ€” Plano, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—