Actively Recruiting
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
Led by Ascidian Therapeutics, Inc · Updated on 2025-12-02
15
Participants Needed
10
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of mutations in the ABCA4 gene
- ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)
- Area of atrophy located in the macula of the study eye
- Best corrected visual acuity of 20/50 (0.4 logMAR) or worse
You will not qualify if you...
- Presence of pathogenic or likely pathogenic mutations in other genes causing cone-rod dystrophy or Stargardt maculopathy
- Retinal disease other than ABCA4-related retinopathy
- Any medical, psychiatric, or physical condition, including substance abuse, that may prevent safe participation or adherence to study visits or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Vitreo Retinal Associates
Gainesville, Florida, United States, 32607
Actively Recruiting
3
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
4
Wilmer Eye Institute at John Hopkins
Baltimore, Maryland, United States, 21218
Actively Recruiting
5
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
7
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45245
Actively Recruiting
8
Casey Eye Institute OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
9
Retina Foundation of the Southwest
Dallas, Texas, United States, 75382
Actively Recruiting
10
Retina Consultants of Texas
Houston, Texas, United States, 77401
Actively Recruiting
Research Team
A
Associate Director, Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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