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NCT06467344 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
A Phase 1 study of Stargardt Disease and Cone-Rod Dystrophy, sponsored by Ascidian Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 10
- Study locations
NCT06467344: Recruiting Phase 1 study of Stargardt Disease and Cone-Rod Dystrophy, sponsored by Ascidian Therapeutics.
NCT06467344 is a Phase 1 study of Stargardt Disease and Cone-Rod Dystrophy that is actively recruiting participants, run by Ascidian Therapeutics. The registered enrollment target is 15 participants, below the 90-participant average among 16 other Stargardt Disease trials with a reported enrollment target (83% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06467344, a Phase 1 study of Stargardt Disease and Cone-Rod Dystrophy, is actively recruiting participants, sponsored by Ascidian Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.
Primary Outcome
To evaluate the safety and tolerability of a single dose of ACDN-01 when administered to participants with ABCA4-related retinopathy.
Conditions Studied
Interventions
- DRUG ACDN-01
Study Locations (10)
Florida
- Vitreo Retinal Associates - Gainesville
- Bascom Palmer Eye Institute - Miami
Texas
- Retina Foundation of the Southwest - Dallas
- Retina Consultants of Texas - Houston
California
- University of San Francisco - San Francisco
Maryland
- Wilmer Eye Institute at John Hopkins - Baltimore
Massachusetts
- Massachusetts Eye and Ear - Boston
Michigan
- University of Michigan Kellogg Eye Center - Ann Arbor
Ohio
- Cincinnati Eye Institute - Cincinnati
Oregon
- Casey Eye Institute OHSU - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2030-12-01 |
| Phase | Phase 1 |
What NCT06467344 shows while recruiting
NCT06467344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 90-participant average among 16 other Stargardt Disease trials with a reported enrollment target (83% lower).
The record links to 4 conditions, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention - of which ACDN-01 is the first listed.
NCT06467344 lists 10 locations in 8 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06467344 about?
NCT06467344 is a clinical study titled "Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)". This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.
What is the current status of trial NCT06467344?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-06-11. Estimated completion is 2030-12-01.
What conditions does trial NCT06467344 study?
This clinical trial studies the following conditions: Stargardt Disease, Cone-Rod Dystrophy, Stargardt Disease 1, Juvenile Macular Degeneration.
What interventions are being tested in trial NCT06467344?
The interventions under investigation include: ACDN-01 (DRUG).
Who is sponsoring clinical trial NCT06467344?
This trial is sponsored by Ascidian Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06467344 being conducted?
This trial has 10 study locations across California, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06467344's enrollment target sits among peer trials
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