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NCT04312672 · ClinicalTrials.gov registry record
Long-term Follow-up Gene Therapy Study for RPGR- XLRP
A clinical trial of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 42
- Enrollment target
- 5
- Study locations
NCT04312672: Completed study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
NCT04312672 is a study of X-Linked Retinitis Pigmentosa that has completed, run by Janssen Research & Development. The registered enrollment target is 42 participants, below the 53-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (21% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04312672, a study of X-Linked Retinitis Pigmentosa, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (ATIMP) AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.
Primary Outcome
Longer-term safety of subretinal AAV5-hRKp.RPGR administered to participants will be reported.
Conditions Studied
Interventions
- BIOLOGICAL AAV5-hRKp.RPGR
Study Locations (5)
Other
- Leeds Teaching Hospitals NHS Trust - Leeds
- Moorfields Eye Hospital - London
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Michigan
- Univ of Michigan Medical Center - Ann Arbor
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2025-09-17 |
What the finished NCT04312672 record still lists
NCT04312672 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 53-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (21% lower).
The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which AAV5-hRKp.RPGR is the first listed.
NCT04312672 lists 5 locations in 4 states (Other, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT04312672 about?
NCT04312672 is a clinical study titled "Long-term Follow-up Gene Therapy Study for RPGR- XLRP". This is a long-term follow-up study assessing safety of patients for up to 60 months following advanced therapy investigational medicinal product (ATIMP) AAV5-hRKp.RPGR vector in participants with XLRP caused by mutations in RPGR.
What is the current status of trial NCT04312672?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2017-07-31. Estimated completion is 2025-09-17.
What conditions does trial NCT04312672 study?
This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.
What interventions are being tested in trial NCT04312672?
The interventions under investigation include: AAV5-hRKp.RPGR (BIOLOGICAL).
Who is sponsoring clinical trial NCT04312672?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04312672 being conducted?
This trial has 5 study locations across Massachusetts, Michigan, Pennsylvania. 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 NCT04312672's enrollment target sits among peer trials
42 5th of 8 higher than 4 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
-
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
-
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
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