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

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

Recruiting
8-55 years
All
Phase 1/2
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  • Simplified (AI rewritten)

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Overview

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

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

Study details
    Stargardt Disease

NCT07161544

AAVantgarde Bio Srl

1 February 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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