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A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
Sponsor: Ocugen
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-06-18
Completion Date
2027-02-12
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Sub-Retinal Administration of OCU400-301
Sub-Retinal Administration of OCU400-301
Locations (17)
Associated Retina Consultants
Phoenix, Arizona, United States
University of Southern Califormia
La Jolla, California, United States
University of Southern California, Roski Eye Insitute
Los Angeles, California, United States
Advanced Research, LLC.
Deerfield Beach, Florida, United States
Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine
Miami, Florida, United States
Erie Retina Research LLC
Erie, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Calgary Retina Consultants
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
The University of British Columbia
Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada