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NCT Number: NCT06445322

Prescreening Study to Identify Potential Stargardt Participants for ACDN-01 Clinical Trials (STARPATH)

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.

Recruiting

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Key information

Conditions

Stargardt Disease Cone Rod Dystrophy Cone-Rod Dystrophies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Juvenile Macular Degeneration Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Dystrophies Stargardt Disease 1

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Presence of mutations in the ABCA4 gene
  • ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)

Key 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.

Treatment and study plan

Prescreening Assessments

Diagnostic Test

Various genetic and visual assessments.

Primary outcomes

  1. Confirm mutations in the ABCA4 gene

    Time frame: 12 months

    Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory.

  2. Confirm the absence of pathogenic mutations in genes known to cause retinal disease other than ABCA4-related retinopathy

    Time frame: 12 months

    Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory.

  3. Measure BCVA and LLVA

    Time frame: 12 months

    Measure best corrected visual acuity and low luminance visual acuity

  4. Measure the area of retinal atrophy

    Time frame: 12 months

    Using FAF imaging

  5. Measure baseline retinal structure

    Time frame: 12 months

    Using OCT (SD-OCT)

  6. Historical FAF or OCT images

    Time frame: 4 years

    Confirm historical timepoint images

  7. Historical BCVA/LLVA measurements

    Time frame: 4 years

    Collect past measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Associate Director, Clinical Operations

CONTACT

[email protected]

207-573-0412

Sponsors and collaborators

Lead sponsor

Ascidian Therapeutics, Inc

Industry

Registry information

Official study title

Prescreening Study to Identify Potential Participants With ABCA4-related Retinopathy for ACDN-01 Clinical Trials

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jun 6, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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