Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-01 @ 10:08 AM
Study NCT ID:
NCT06377150
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2024-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABCA4-associated Disease in Childhood and Adolescence - a Phenotype Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080362', 'term': 'Stargardt Disease'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-19', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'January 2014 - May 2021', 'description': 'best corrected visual acuity'}, {'measure': 'Visual Field (VF)', 'timeFrame': 'January 2014 - May 2021', 'description': 'visual field as measured by semi-automated 90° kinetic visual field exam using target III4e'}, {'measure': 'Fundus Photography (FP)', 'timeFrame': 'January 2014 - May 2021', 'description': 'characterization of the retina with fundus photography'}, {'measure': 'Fundus Autofluorescence (AF)', 'timeFrame': 'January 2014 - May 2021', 'description': 'characterization of the retina with fundus autofluorescence'}, {'measure': 'Optical Coherence Tomography (OCT)', 'timeFrame': 'January 2014 - May 2021', 'description': 'characterization of the retina with optical coherence tomography, e.g. foveal ellipsoid zone loss'}, {'measure': 'Full-Field Electroretinography (ff-ERG)', 'timeFrame': 'January 2014 - May 2021', 'description': 'characterization of retinal function with full-field electroretinogram'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stargardt Disease', 'ABCA4', 'inherited retinal dystrophy'], 'conditions': ['Stargardt Disease']}, 'descriptionModule': {'briefSummary': 'Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with genetically confirmed ABCA4-associated inherited retinal dystrophy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* genetically confirmed ABCA4-associated inherited retinal dystrophy\n\nExclusion Criteria:\n\n* 18 years old and older'}, 'identificationModule': {'nctId': 'NCT06377150', 'briefTitle': 'ABCA4-associated Disease in Childhood and Adolescence - a Phenotype Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'ABCA4-associated Disease in Childhood and Adolescence - a Phenotype Study', 'orgStudyIdInfo': {'id': 'ABCA4-1382022BO2'}}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wuerttemberg, Germany', 'country': 'Germany', 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Laura Kuehlewein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ophthalmology, University of Tuebingen'}, {'name': 'Susanne Kohl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Molecular Genetics Laboratory, Centre for Ophthalmology, University of Tuebingen'}, {'name': 'Jan-Philipp Bodenbender, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Ophthalmology, University of Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}