Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT03897192
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080363', 'term': 'White Dot Syndromes'}, {'id': 'D000080364', 'term': 'Multifocal Choroiditis'}], 'ancestors': [{'id': 'D015866', 'term': 'Uveitis, Posterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002833', 'term': 'Choroiditis'}, {'id': 'D015862', 'term': 'Choroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-28', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wilcoxon Signed-Rank test', 'timeFrame': 'Baseline, 4 year', 'description': 'A statistical comparison of average of different time point'}], 'secondaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'Baseline, 6 month, 12 month, 24 month, 36 month, 48 month', 'description': 'visual acuity change in logMAR in different time point'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['punctate inner choroidopathy', 'multifocal choroiditis', 'zonal outer retinopathy', 'long-term outcome'], 'conditions': ['Punctate Inner Choroidopathy']}, 'descriptionModule': {'briefSummary': 'To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We included patients of PIC/MFC and ZOR with a clinical follow up of 4 years or longer. Patients were recorded of age, sex, best corrected visual acuity (BCVA), refractive status, coexistence of choroidal neovascularization, number and total area of PIC/MFC lesions, treatment, and recurrent activity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).\n* Follow up over 4 years.\n\nExclusion Criteria:\n\n* Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).'}, 'identificationModule': {'nctId': 'NCT03897192', 'briefTitle': 'Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor', 'orgStudyIdInfo': {'id': '190318'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Anti-vascular endothelial growth factor (VEGF)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Ophthalmology', 'investigatorFullName': 'San Ni Chen', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}}