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OpenTrials
Completed

NCT Number: NCT06377150

ABCA4-associated Disease in Childhood and Adolescence - a Phenotype Study

Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease.

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Key information

Conditions

Stargardt Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen

Tübingen, Baden-Wuerttemberg, Germany, 72076, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • genetically confirmed ABCA4-associated inherited retinal dystrophy

Exclusion criteria

  • 18 years old and older

Treatment and study plan

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: January 2014 - May 2021

    best corrected visual acuity

  2. Visual Field (VF)

    Time frame: January 2014 - May 2021

    visual field as measured by semi-automated 90° kinetic visual field exam using target III4e

  3. Fundus Photography (FP)

    Time frame: January 2014 - May 2021

    characterization of the retina with fundus photography

  4. Fundus Autofluorescence (AF)

    Time frame: January 2014 - May 2021

    characterization of the retina with fundus autofluorescence

  5. Optical Coherence Tomography (OCT)

    Time frame: January 2014 - May 2021

    characterization of the retina with optical coherence tomography, e.g. foveal ellipsoid zone loss

  6. Full-Field Electroretinography (ff-ERG)

    Time frame: January 2014 - May 2021

    characterization of retinal function with full-field electroretinogram

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Jun 29, 2025

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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