Trials / NCT06388200
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
Underway, not enrolling Phase 3 Gene therapy
- Sponsor
- Ocugen
- Treatment
- Sub-Retinal Administration of OCU400-301
- Gene
- Not gene-specific (mentions NR2E3, RHO)
- Conditions
- Retinitis Pigmentosa
- Ages
- 3 Years to no upper limit
- Enrollment
- 140 participants
- Started
- 2024-06-18
- Main results expected
- 2027-02-12
- Results posted
- Not yet
- Record last updated
- 2026-07-31
What the study is testing
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.
Where it runs
Canada (5)
- 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
United States (12)
- 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