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

Last updated: May 12, 2025
Sponsor: Ascidian Therapeutics, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Geographic Atrophy

Myopic Macular Degeneration

Treatment

Prescreening Assessments

Clinical Study ID

NCT06445322
ACDN-01-000
  • Ages > 5
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Presence of mutations in the ABCA4 gene

  • ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)

Exclusion

Key Exclusion Criteria:

  • The presence of pathogenic or likely pathogenic mutations in other genes known tocause 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 findingthat may in the opinion of the principal investigator and sponsor preclude adherenceto the scheduled study visits, safe participation in the study, or affect theresults of the study.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Prescreening Assessments
Phase:
Study Start date:
June 20, 2024
Estimated Completion Date:
August 31, 2030

Study 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.

Connect with a study center

  • University of San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Vitreo Retinal Associates

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Wilmer Eye Institute at John Hopkins

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45245
    United States

    Active - Recruiting

  • Retina Foundation of Texas

    Dallas, Texas 75382
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Houston, Texas 77401
    United States

    Active - Recruiting

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