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NCT04671433 · ClinicalTrials.gov registry record · Phase 3
Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
A Phase 3 study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT04671433: Completed Phase 3 study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
NCT04671433 is a Phase 3 study of X-Linked Retinitis Pigmentosa that has completed, run by Janssen Research & Development. The registered enrollment target is 105 participants, above the 45-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (133% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04671433, a Phase 3 study of X-Linked Retinitis Pigmentosa, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Primary Outcome
Change from baseline to Week 52 in VMA as measured by the ability of the participant to navigate through a VMA maze.
Conditions Studied
Interventions
- BIOLOGICAL Genetic: AAV5-hRKp.RPGR
Study Locations (20)
Other
- UZ Gent - Ghent
- Rigshospitalet Glostrup - Glostrup Municipality
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts - Paris
- Hadassah Medical Center - Jerusalem
- Azienda Ospedaliero Universitaria Careggi - Florence
- Ospedale San Paolo - Milan
- Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli - Naples
- IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS - Roma
- VUMC Amsterdam - Amsterdam
California
- Shiley Eye Institute Jacobs Retina Center - La Jolla
- Childrens Hospital - Los Angeles
- Stanford Health Care - Palo Alto
Florida
- VitreoRetinal Associates, PA - Gainesville
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Center for Celiac Research and Treatment - Boston
Michigan
- Univ of Michigan Medical Center - Ann Arbor
North Carolina
- Duke Eye Center - Durham
Pennsylvania
- University of Pittsburgh Medical Center (UPMC) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2020-12-04 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 3 |
What the finished NCT04671433 record still lists
NCT04671433 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (133% higher).
The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which Genetic: AAV5-hRKp.RPGR is the first listed.
NCT04671433 names 20 study sites across 10 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04671433 about?
NCT04671433 is a clinical study titled "Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene". A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
What is the current status of trial NCT04671433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2020-12-04. Estimated completion is 2024-09-30.
What conditions does trial NCT04671433 study?
This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.
What interventions are being tested in trial NCT04671433?
The interventions under investigation include: Genetic: AAV5-hRKp.RPGR (BIOLOGICAL).
Who is sponsoring clinical trial NCT04671433?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04671433 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for X-Linked Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04671433's enrollment target sits among peer trials
105 1st of 8 higher than 8 of 8 other X-Linked Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other X-Linked Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
ACTIVE NOT RECRUITING · Phase 3
-
A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)
ACTIVE NOT RECRUITING · Phase 2
-
4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 1
-
A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 2
-
A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP
ACTIVE NOT RECRUITING · Phase 2
-
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
ACTIVE NOT RECRUITING · Phase 1
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