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A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
NCT07161544 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL AAVB-039
Study Locations (6)
Texas
- Retina Consultants of Texas — Bellaire
- Retina Foundation of the Southwest — Dallas
England
- Moorfields Eye Hospital NHS Foundation Trust — London
- The Retina Clinic — London
California
- Retina Vitreous Associates Medical Group — Los Angeles
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2032-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07161544
The ClinicalTrials.gov registry entry for NCT07161544 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AAVantgarde Bio Srl, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention — of which AAVB-039 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07161544 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Texas, England, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07161544 about?
NCT07161544 is a clinical study titled "A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)". 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.
What is the current status of trial NCT07161544?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2025-09-29. Estimated completion is 2032-07.
What conditions does trial NCT07161544 study?
This clinical trial studies the following conditions: Stargardt Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07161544?
The interventions under investigation include: AAVB-039 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07161544?
This trial is sponsored by AAVantgarde Bio Srl, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07161544 being conducted?
This trial has 6 study locations across California, Minnesota, Texas, England. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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