Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT02000102
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2013-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-17', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Central Subfield Thickness on Optical Coherence Tomography', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Patients with diabetic macular edema who were switched to aflibercept after having been treated with bevacizumab or ranibizumab were retrospectively reviewed to assess for visual acuity and anatomic outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Those patients with diabetic macular edema switched to aflibercept from bevacizumab and/or ranibizumab -\n\nExclusion Criteria: None\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02000102', 'briefTitle': 'Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'orgStudyIdInfo': {'id': '28279'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic Macular Edema Patients Switched to Aflibercept', 'interventionNames': ['Drug: Intravitreal Injection of Aflibercept']}], 'interventions': [{'name': 'Intravitreal Injection of Aflibercept', 'type': 'DRUG', 'armGroupLabels': ['Diabetic Macular Edema Patients Switched to Aflibercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}