Actively Recruiting

Phase 1
Phase 2
Age: 8Years - 55Years
All Genders
NCT07161544

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

Led by AAVantgarde Bio Srl · Updated on 2026-03-09

75

Participants Needed

6

Research Sites

352 weeks

Total Duration

On this page

Sponsors

A

AAVantgarde Bio Srl

Lead Sponsor

A

AAVantgarde Bio UK Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 8Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Molecular diagnosis of Stargardt disease due to ABCA4 mutation
  • Willingness to adhere to protocol per informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Retina Vitreous Associates Medical Group

Los Angeles, California, United States, 90211

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

3

Retina Consultants of Texas

Bellaire, Texas, United States, 77401

Actively Recruiting

4

Retina Foundation of the Southwest

Dallas, Texas, United States, 75231

Actively Recruiting

5

Moorfields Eye Hospital NHS Foundation Trust

London, England, United Kingdom, EC1V 2PD

Actively Recruiting

6

The Retina Clinic

London, England, United Kingdom, W1G 9AX

Actively Recruiting

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Research Team

A

AAVantgarde Clinical Operations Lead

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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