Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 12:03 PM
Study NCT ID:
NCT02933905
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2016-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-14', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in best-corrected visual acuity', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Change in central macular thickness', 'timeFrame': 'One year'}, {'measure': 'Number of ranibizumab injections', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema', 'Vitreomacular Interface', 'Anti-VEGF Treatment']}, 'descriptionModule': {'briefSummary': 'Influence of the vitreomacular interface on the progression of diabetic macular edema after treatment with intravitreal injection of vascular endothelial growth factor inhibitors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabetic macular edema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic macular edema treatable with antiangiogenic drugs\n\nExclusion Criteria:\n\n* age under 18\n* cardiovascular events during the last year\n* previous vitrectomy\n* previous macular edema treatment during the last 4 months'}, 'identificationModule': {'nctId': 'NCT02933905', 'briefTitle': 'Influence of the Vitreomacular Interface on the Progression of the Diabetic Macular Edema After Anti-VEGF Injection', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Institut Germans Trias i Pujol'}, 'orgStudyIdInfo': {'id': 'OFT-RAN-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-PVD subjects', 'description': 'Patients with no PVD on SD-OCT at basal visit', 'interventionNames': ['Drug: Intravitreal Ranibizumab injection']}, {'label': 'PVD subjects', 'description': 'Patients with PVD on SD-OCT at basal visit', 'interventionNames': ['Drug: Intravitreal Ranibizumab injection']}], 'interventions': [{'name': 'Intravitreal Ranibizumab injection', 'type': 'DRUG', 'armGroupLabels': ['Non-PVD subjects', 'PVD subjects']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Institut Germans Trias i Pujol', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FEBO', 'investigatorFullName': 'Xavier Valldeperas', 'investigatorAffiliation': 'Fundació Institut Germans Trias i Pujol'}}}}