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Clinical Trials in Italy / NCT06591793
Recruiting Phase 1/2

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

NCT06591793 · tracked via the Priya Life Science Italy tracker
Sponsor
AAVantgarde Bio Srl
Phase
Phase 1/2
Started
2024-07-02
Last updated
2025-05-02

Condition(s) studied

Usher Syndrome, Type 1B

Investigational drug(s) / intervention(s)

AAVB-081

AAVB-081: Single subretinal administration

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

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • To measure the number and severity of treatment related adverse events following treatment with AAVB-081 — 61 months

Trial sites (3)

FacilityCityRegionStatus
University of Campania Luigi Vanvitelli Naples Italy Recruiting
Moorfields Eye Hospital London United Kingdom Recruiting
Retina Clinic London London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06591793 on ClinicalTrials.gov ↗ ← All trials in Italy