A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa (NCT06388200)
A Phase 3, Multi-Center, Randomized Study to Assess The Efficacy, Safety and Tolerability of Subretinal OCU400 Gene Therapy for the Treatment of Retinitis Pigmentosa
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP. This is a multicenter, assessor blinded and randomized study which will enroll 140 subjects. Study has completed enrollment of all 140 subjects.
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants — Phoenix, Arizona
Age range: 3 Years
🧪 Interventions in This Study
- Sub-Retinal Administration of OCU400-301 (GENETIC)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Associated Retina Consultants — Phoenix, Arizona
- University of Southern Califormia — La Jolla, California
- University of Southern California, Roski Eye Insitute — Los Angeles, California
- Advanced Research, LLC. — Deerfield Beach, Florida
- Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine — Miami, Florida
- Erie Retina Research LLC — Erie, Pennsylvania
- Vanderbilt Eye Institute — Nashville, Tennessee
- Retina Consultants of Texas — Bellaire, Texas
- Retina Foundation of the Southwest — Dallas, Texas
- Baylor College of Medicine — Houston, Texas
- Valley Retina Institute — McAllen, Texas
- Gundersen Health System — La Crosse, Wisconsin
- Calgary Retina Consultants — Calgary, Alberta
- University of Alberta — Edmonton, Alberta
- The University of British Columbia — Vancouver, British Columbia
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- Research Institute of the McGill University Health Centre — Montreal, Quebec
💰 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 § 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.
More studies in Retinitis Pigmentosa
- Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP) — Phoenix, Arizona
- Natural History of PRPF31 Mutation-Associated Retinal Dystrophy — San Francisco, California
- Prospective Natural History Study of Retinitis Pigmentosa — Pittsburgh, Pennsylvania
- Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa or Choroideremia Patients (ENVISION) — Beverly Hills, California
- FIGHT-RP 1 Extension Study — Baltimore, Maryland
- Promising ROd-cone DYstrophy Gene therapY — Miami, Florida
Explore by condition: All Retinitis Pigmentosa clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.