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Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Sponsor: AAVantgarde Bio Srl
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. The study will also assess the initial efficacy following AAVB-081 administration.
Official title: A Phase 1/2 Multicenter, Open-label, Dose Escalation, Safety and Efficacy Study of Subretinal Administration of Dual AAV8.MYO7A, AAVB-081 in Subjects With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-07-02
Completion Date
2029-07
Last Updated
2025-05-02
Healthy Volunteers
No
Conditions
Interventions
AAVB-081
Single subretinal administration
Locations (3)
University of Campania Luigi Vanvitelli
Naples, Italy
Moorfields Eye Hospital
London, United Kingdom
Retina Clinic London
London, United Kingdom