RecruitingNCT06445322

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

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


Sponsor

Ascidian Therapeutics, Inc

Enrollment

50 participants

Start Date

Jun 20, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 5 Years

Inclusion Criteria2

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

Exclusion Criteria3

  • 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.

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Interventions

DIAGNOSTIC_TESTPrescreening Assessments

Various genetic and visual assessments.


Locations(8)

University of San Francisco

San Francisco, California, United States

Vitreo Retinal Associates

Gainesville, Florida, United States

Wilmer Eye Institute at John Hopkins

Baltimore, Maryland, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Retina Foundation of Texas

Dallas, Texas, United States

Retina Consultants of Texas

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06445322


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