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Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
Sponsor: Janssen Research & Development, LLC
Summary
A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Official title: Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
Key Details
Gender
All
Age Range
3 Years - Any
Study Type
INTERVENTIONAL
Enrollment
97
Start Date
2020-12-04
Completion Date
2029-12-07
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Genetic: AAV5-hRKp.RPGR Intermediate Dose
Bilateral, subretinal administration of AAV5-hRKp.RPGR - deferred treatment group
Genetic: AAV5-hRKp.RPGR Low Dose
Bilateral, subretinal administration of AAV5-hRKp.RPGR - deferred treatment group
Locations (25)
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Stanford Health Care
Palo Alto, California, United States
VitreoRetinal Associates, PA
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Univ of Michigan Medical Center
Ann Arbor, Michigan, United States
Duke Eye Center
Durham, North Carolina, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Ghent University Hospital
Ghent, Belgium
Hospital For Sick Children
Toronto, Ontario, Canada
Rigshospitalet Glostrup
Glostrup Municipality, Denmark
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France
Hadassah Medical Center
Jerusalem, Israel
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
Naples, Italy
VUMC Amsterdam
Amsterdam, Netherlands
Radboudumc
Nijmegen, Netherlands
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical
Basel, Switzerland
Universite de Lausanne, Hopital ophtalmique Jules-Gonin
Lausanne, Switzerland
NHS Lothian
Edinburgh, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
St James University Hospital
Leeds, United Kingdom
Moorfields Eye Hospital
London, United Kingdom