ong term follow-up study of gene therapy trial for X-linked Retinitis Pigmentosa
- Conditions
- X-Linked Retinitis Pigmentosa caused by mutations in the RPGR geneMedDRA version: 20.0Level: PTClassification code 10038914Term: Retinitis pigmentosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2018-000425-31-Outside-EU/EEA
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion in the study will be limited to individuals who meet the following criteria:
• Are able to give informed consent or assent, with or without the guidance of their parent/guardian where appropriate
• Received AAV5-hRKp.RPGR by sub retinal administration in the prior open-label, Phase I/II, dose escalation study (EudraCT 2016-003967-21)
• Are willing to adhere to the protocol and long-term follow-up
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method