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

Ascidian Therapeutics, Inc50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Stargardt Disease Stargardt Disease 1 Cone Rod Dystrophy Juvenile Macular Degeneration

Interventions

Prescreening AssessmentsDIAGNOSTIC_TEST

Various genetic and visual assessments.

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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.

Locations (8)

University of San Francisco

San Francisco, California, United States

RECRUITING

Vitreo Retinal Associates

Gainesville, Florida, United States

RECRUITING

Wilmer Eye Institute at John Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Confirm mutations in the ABCA4 gene

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

Time frame: 12 months

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

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

Time frame: 12 months

Measure BCVA and LLVA

Measure best corrected visual acuity and low luminance visual acuity

Time frame: 12 months

Measure the area of retinal atrophy

Using FAF imaging

Time frame: 12 months

Measure baseline retinal structure

Using OCT (SD-OCT)

Time frame: 12 months

Historical FAF or OCT images

Confirm historical timepoint images

Time frame: 4 years

Historical BCVA/LLVA measurements

Collect past measurements

Time frame: 4 years

Central Contacts

Associate Director, Clinical Operations

CONTACT

207-573-0412 researchtrials@ascidian-tx.com

Data from ClinicalTrials.gov

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