Status:
COMPLETED
Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
X-Linked Retinitis Pigmentosa
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Eligibility Criteria
Inclusion
- Male or female
- 3 years of age or older
- Has XLRP confirmed by a retinal specialist and has a predicted disease-causing sequence variant in RPGR confirmed by an accredited laboratory
Exclusion
- Has had ocular surgery within 3 months prior to screening or is anticipated to require ocular surgery within 6 months after the study intervention administration
- Any investigational ocular treatment or any other ocular treatment that could confound the interpretation of the efficacy results or affect participant compliance with the visit schedule
- Has undergone prior retinal surgery involving the macula, macular laser photocoagulation, external-beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04671433
Start Date
December 4 2020
End Date
September 30 2024
Last Update
September 29 2025
Active Locations (27)
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1
Shiley Eye Institute Jacobs Retina Center
La Jolla, California, United States, 92093 0946
2
Childrens Hospital
Los Angeles, California, United States, 90027
3
Stanford Health Care
Palo Alto, California, United States, 94303
4
VitreoRetinal Associates, PA
Gainesville, Florida, United States, 32607