Status:
TERMINATED
Safety and Efficacy Study in Patients With Retinitis Pigmentosa Due to Mutations in PDE6B Gene
Lead Sponsor:
eyeDNA Therapeutics
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
13+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study is a Phase I/II, monocentric, open-label, dose-ranging safety and efficacy gene therapy intervention by subretinal administration of AAV2/5-hPDE6B. At least twelve patients 18 years of age ...
Detailed Description
Retinitis pigmentosa (RP) is a disease where part of the eye (the retina) is degenerating over time. Patients initially present with night blindness, and later in life experience loss of central visio...
Eligibility Criteria
Inclusion
- Key
- Clinical and molecular diagnosis of retinitis pigmentosa caused by defect in PDE6B gene without other syndromic manifestations
- Aged above 13 years
- Ability to give informed consent
- Key
Exclusion
- Previous ocular surgery or thermal laser within 6 months before the surgery
- Lens opacities or obscured ocular media upon recruitment such reliable evaluation or grading of the posterior segment cannot be performed
- Known serious allergies to the fluorescein dye used in angiography, to the mydriatic, steroidal and non-steroidal eye drops
- Participation in another clinical trial with an investigational agent
- Enrolled or being enrolled in another gene therapy clinical trial
- Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents
- Chronic medical conditions, cancer
- Abnormal laboratory values
- On immunosuppressive therapy
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03328130
Start Date
November 6 2017
End Date
June 30 2025
Last Update
December 18 2025
Active Locations (1)
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1
Clinique Ophtalmologique, CHU de Nantes
Nantes, France, 44093