Stargardt Disease in Childhood

Completed

• Conditions: Stargardt Disease

• Registration Number: NCT06377150
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• genetically confirmed ABCA4-associated inherited retinal dystrophy

Exclusion Criteria

• 18 years old and older

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany, Germany