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Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa

Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa

Recruiting
18-50 years
All
Phase 1/2
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Overview

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.

Eligibility

Inclusion Criteria:

  • Molecular diagnosis of USB1B due to MYO7A mutation
  • Willingness to adhere to protocol per informed consent

Exclusion Criteria:

  • 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

Study details
    Usher Syndrome
    Type 1B

NCT06591793

AAVantgarde Bio Srl

15 October 2025

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