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NCT07161544 · ClinicalTrials.gov registry record · Phase 1
A Study of AAVB-039 in Participants With Stargardt Disease (STGD1)
A Phase 1 study of Stargardt Disease, sponsored by AAVantgarde Bio Srl.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 6
- Study locations
NCT07161544: Recruiting Phase 1 study of Stargardt Disease, sponsored by AAVantgarde Bio Srl.
NCT07161544 is a Phase 1 study of Stargardt Disease that is actively recruiting participants, run by AAVantgarde Bio Srl. The registered enrollment target is 75 participants, below the 87-participant average among 16 other Stargardt Disease trials with a reported enrollment target (14% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07161544, a Phase 1 study of Stargardt Disease, is actively recruiting participants, sponsored by AAVantgarde Bio Srl.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 6
- Study locations
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 |
What NCT07161544 shows while recruiting
NCT07161544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 87-participant average among 16 other Stargardt Disease trials with a reported enrollment target (14% lower).
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.
NCT07161544 lists 6 locations in 4 states (Texas, England, California).
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.
What interventions are being tested in trial NCT07161544?
The interventions under investigation include: AAVB-039 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07161544?
This trial is sponsored by AAVantgarde Bio Srl, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT07161544's enrollment target sits among peer trials
75 6th of 16 higher than 10 of 16 other Stargardt Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stargardt Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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