Trials / Active Not Recruiting
Active Not RecruitingNCT05926583
A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa
Phase 3 Study to Evaluate the Safety and Efficacy of AAV5-hRKp.RPGR for the Treatment of Japanese X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Janssen Pharmaceutical K.K. · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-09-12
- Primary completion
- 2027-06-30
- Completion
- 2030-11-12
- First posted
- 2023-07-03
- Last updated
- 2026-04-13
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05926583. Inclusion in this directory is not an endorsement.