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Recruiting NCT07161544

A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)

Conditions: Stargardt Disease

Sex: All

Ages: 8 Years – 55 Years

Healthy volunteers: No

Phase: PHASE1, PHASE2

Enrollment: 75

Sponsor: AAVantgarde Bio Srl

Location: Associated Retina Consultants Phoenix Arizona

Summary

The purpose of the 039-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-039 in participants with Stargardt disease secondary to a biallelic mutation of the ABCA4 gene. The study will also assess initial efficacy following AAVB-039 administration.

Eligibility Criteria

Inclusion Criteria: * Molecular diagnosis of Stargardt disease due to ABCA4 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 another Investigation Medicinal Product * Previous participation in another gene or cell therapy trial * Any condition that would preclude subretinal surgery * Complicating ocular and/or systemic diseases

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07161544). StuddyBuddy aggregates publicly available trial information.