Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Molecular diagnosis of Stargardt disease due to ABCA4 mutation
- Willingness to adhere to protocol per informed consent
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
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
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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