Actively Recruiting
Prescreening Study to Identify Potential Participants With ABCA4-related Retinopathy for ACDN-01 Clinical Trials
Led by Ascidian Therapeutics, Inc · Updated on 2026-03-11
50
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational prescreening study focuses on individuals with Stargardt disease and related ABCA4 gene mutations. It aims to identify potential participants for future ACDN-01 clinical trials by assessing key eligibility criteria before formal trial screening. The study is sponsored by Ascidian Therapeutics, Inc and targets people with ABCA4-related retinopathy, including Stargardt disease type 1 and cone-rod dystrophy. Participants will undergo genetic and visual assessments during at least one onsite visit. These tests include confirming mutations in the ABCA4 gene, measuring visual acuity (BCVA and LLVA), retinal atrophy area, and retinal structure. Historical imaging and vision test data may also be reviewed to support eligibility evaluation. During the study, researchers will collect data on the participant's genetic status and eye health to determine suitability for ACDN-01 clinical trials. Assessments involve genetic testing, vision measurements, and retinal imaging. The primary outcomes include confirmation of gene mutations and detailed eye examinations over a 12-month period, with some historical data collected for up to 4 years. Participants' safety and adherence to study visits are monitored throughout the process.
CONDITIONS
Brief Title
Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)
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)
You will not qualify if you...
- Presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or Stargardt maculopathy
- Retinal disease other than ABCA4-related retinopathy
- Medical condition (systemic or ophthalmic), psychiatric condition including substance abuse disorder, or examination or lab findings that may affect safe participation or study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo genetic and visual assessments to determine eligibility for further ACDN-01 clinical trials.
At least 1 onsite visit
Duration - Up to 4 years
Participants' historical imaging and visual acuity data are reviewed to support eligibility assessment.
No visits required; data collected from medical history
Trial Site Locations
Total: 8 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
Wilmer Eye Institute at John Hopkins
Baltimore, Maryland, United States, 21218
Actively Recruiting
4
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
6
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45245
Actively Recruiting
7
Retina Foundation of Texas
Dallas, Texas, United States, 75382
Actively Recruiting
8
Retina Consultants of Texas
Houston, Texas, United States, 77401
Actively Recruiting
Research Team
A
Associate Director, Clinical Operations
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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