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

Last updated: May 1, 2025
Sponsor: AAVantgarde Bio Srl
Overall Status: Active - Recruiting

Phase

1/2

Condition

Eye Disorders/infections

Retinitis Pigmentosa

Posterior Uveitis

Treatment

AAVB-081

Clinical Study ID

NCT06591793
081-101
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Molecular diagnosis of USB1B due to MYO7A mutation

  • Willingness to adhere to protocol per informed consent

Exclusion

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 Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: AAVB-081
Phase: 1/2
Study Start date:
July 02, 2024
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • University of Campania Luigi Vanvitelli

    Naples,
    Italy

    Active - Recruiting

  • Moorfields Eye Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Retina Clinic London

    London,
    United Kingdom

    Active - Recruiting

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