Trials / Completed
CompletedNCT04671433
Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
Phase 3 Randomized, Controlled Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Genetic: AAV5-hRKp.RPGR | Bilateral, sub-retinal administration of AAV5-hRKp.RPGR - immediate treatment group |
| BIOLOGICAL | Genetic: AAV5-hRKp.RPGR | No intervention - deferred treatment group (Bilateral, sub-retinal administration of AAV5-hRKp.RPGR to be administered in the follow-up study) |
Timeline
- Start date
- 2020-12-04
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
- First posted
- 2020-12-17
- Last updated
- 2026-03-16
Locations
28 sites across 11 countries: United States, Belgium, Canada, Denmark, France, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04671433. Inclusion in this directory is not an endorsement.