Status:
RECRUITING
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Lead Sponsor:
AAVantgarde Bio Srl
Conditions:
Usher Syndrome, Type 1B
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-081 in USH1B patients with retinitis pigmentosa due to a mutation in the MYO7A gene...
Eligibility Criteria
Inclusion
- Molecular diagnosis of USB1B due to MYO7A mutation
- Willingness to adhere to protocol per informed consent
Exclusion
- Unwillingness to meet the requirements of the study
- Participation in a clinical study with an Investigation Product in the past 6 months
- Previous participation in another Gene Therapy trial
- Any condition that would preclude subretinal surgery
- Complicating ocular and/or systemic diseases
Key Trial Info
Start Date :
July 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06591793
Start Date
July 2 2024
End Date
July 1 2029
Last Update
May 2 2025
Active Locations (3)
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1
University of Campania Luigi Vanvitelli
Naples, Italy
2
Moorfields Eye Hospital
London, United Kingdom
3
Retina Clinic London
London, United Kingdom