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NCT06377150 Clinical Trial

Stargardt Disease in Childhood

Stargardt Disease Clinical Trial

Official title:
Stargardt Disease in Childhood - a Single-center Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06377150
Other study ID # ABCA4-1382022BO2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date March 31, 2024

Study information
Verified date April 2024
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - genetically confirmed ABCA4-associated inherited retinal dystrophy Exclusion Criteria: - 18 years old and older

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen Baden-Wuerttemberg, Germany

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity (BCVA) best corrected visual acuity January 2014 - May 2021
Primary Visual Field (VF) visual field as measured by semi-automated 90° kinetic visual field exam using target III4e January 2014 - May 2021
Primary Fundus Photography (FP) characterization of the retina with fundus photography January 2014 - May 2021
Primary Fundus Autofluorescence (AF) characterization of the retina with fundus autofluorescence January 2014 - May 2021
Primary Optical Coherence Tomography (OCT) characterization of the retina with optical coherence tomography, e.g. foveal ellipsoid zone loss January 2014 - May 2021
Primary Full-Field Electroretinography (ff-ERG) characterization of retinal function with full-field electroretinogram January 2014 - May 2021
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