Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)
Purpose
This is an observational prescreening study. Individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in ACDN-01 clinical trials.
Conditions
- Stargardt Disease
- Stargardt Disease 1
- Cone Rod Dystrophy
- Juvenile Macular Degeneration
Eligibility
- Eligible Ages
- Over 5 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Presence of mutations in the ABCA4 gene - ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)
Exclusion Criteria
- The 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 - Presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Prescreening Group | The prescreening study consists of genetic and visual assessments and will require at least 1 onsite visit. All clinical assessments performed are for the purpose of determining research eligibility for ACDN-01 clinical trials. |
|
Recruiting Locations
University of San Francisco
San Francisco, California 94158
San Francisco, California 94158
Vitreo Retinal Associates
Gainesville, Florida 32607
Gainesville, Florida 32607
Wilmer Eye Institute at John Hopkins
Baltimore, Maryland 21218
Baltimore, Maryland 21218
Massachusetts Eye and Ear
Boston, Massachusetts 02114
Boston, Massachusetts 02114
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan 48105
Ann Arbor, Michigan 48105
Cincinnati Eye Institute
Cincinnati, Ohio 45245
Cincinnati, Ohio 45245
Retina Foundation of Texas
Dallas, Texas 75382
Dallas, Texas 75382
Retina Consultants of Texas
Houston, Texas 77401
Houston, Texas 77401
More Details
- NCT ID
- NCT06445322
- Status
- Recruiting
- Sponsor
- Ascidian Therapeutics, Inc
Detailed Description
The prescreening process will be used to help determine the initial eligibility and interest of potential participants in ACDN-01 clinical trials by conducting assessments of key eligibility criteria before the clinical trial screening procedures are performed.