A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa
NCT05926583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-05-08
Summary
The purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (AAV5-hRKp.RPGR).
Conditions
Interventions
- GENETIC
-
AAV5-hRKp.RPGR
AAV5-hRKp.RPGR will be administered by subretinal injection using a standardized surgical procedure.
- GENETIC
-
AAV5-hRKp.RPGR
AAV5-hRKp.RPGR will be administered by subretinal injection using a standardized surgical procedure.
Sponsors & Collaborators
-
Janssen Pharmaceutical K.K.
lead INDUSTRY
Principal Investigators
-
Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-12
- Primary Completion
- 2027-06-30
- Completion
- 2030-11-12
Countries
- Japan
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