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NCT06646289 · ClinicalTrials.gov registry record · Phase 2
A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
A Phase 2 study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT06646289: Active Phase 2 study of X-Linked Retinitis Pigmentosa, sponsored by Janssen Research & Development.
NCT06646289 is a Phase 2 study of X-Linked Retinitis Pigmentosa that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 24 participants, below the 55-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (56% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06646289, a Phase 2 study of X-Linked Retinitis Pigmentosa, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non inv
Conditions Studied
Interventions
- BIOLOGICAL AAV5-hRKp.RPGR
- OTHER No intervention (Follow-Up assessment)
Study Locations (3)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Michigan
- University of Michigan Kellogg Eye Center - Ann Arbor
Other
- Moorfields Eye Hospital - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2030-10-24 |
| Phase | Phase 2 |
What the registry record for NCT06646289 still lists
NCT06646289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 55-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target (56% lower).
The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 2 interventions - of which AAV5-hRKp.RPGR is the first listed.
NCT06646289 reports a single indexed study location in Massachusetts, Michigan, Other.
Frequently Asked Questions
What is clinical trial NCT06646289 about?
NCT06646289 is a clinical study titled "A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)". The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.
What is the current status of trial NCT06646289?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2024-10-10. Estimated completion is 2030-10-24.
What conditions does trial NCT06646289 study?
This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.
What interventions are being tested in trial NCT06646289?
The interventions under investigation include: AAV5-hRKp.RPGR (BIOLOGICAL), No intervention (Follow-Up assessment) (OTHER).
Who is sponsoring clinical trial NCT06646289?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06646289 being conducted?
This trial has 3 study locations across 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 NCT06646289's enrollment target sits among peer trials
24 7th of 8 higher than 2 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
-
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
-
4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 1
-
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
-
Long-term Follow-up Gene Therapy Study for RPGR- XLRP
COMPLETED
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