Actively Recruiting
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Led by AAVantgarde Bio Srl · Updated on 2025-05-02
15
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Molecular diagnosis of USB1B due to MYO7A mutation
- Willingness to adhere to protocol per informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Campania Luigi Vanvitelli
Naples, Italy
Actively Recruiting
2
Moorfields Eye Hospital
London, United Kingdom
Actively Recruiting
3
Retina Clinic London
London, United Kingdom
Actively Recruiting
Research Team
C
Clinical Operations Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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