Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-02-11 @ 12:34 AM
Study NCT ID:
NCT02126904
Status:
UNKNOWN
Last Update Posted:
2014-04-30
First Post:
2014-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2014-04-27', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recurrence after induction phase', 'timeFrame': 'More than 3 months from baseline', 'description': 'Time frame depends on patients because recurrence time is different.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['The Injection Burden']}, 'descriptionModule': {'briefSummary': 'The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients were treated at Yokohama City University Medical Center between January 2012 and October 2013.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.\n\nExclusion Criteria:\n\n* patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.'}, 'identificationModule': {'nctId': 'NCT02126904', 'briefTitle': 'Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University Medical Center'}, 'officialTitle': 'Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': '1310006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IVR group', 'interventionNames': ['Drug: IVA group']}], 'interventions': [{'name': 'IVA group', 'type': 'DRUG', 'armGroupLabels': ['IVR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Maiko Inoue, M.D.', 'role': 'CONTACT', 'email': 'maicoo@urahp.yokohama-cu.ac.jp', 'phone': '81 45 261 5656', 'phoneExt': '7458'}, {'name': 'Maiko Inoue, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maiko Inoue', 'investigatorAffiliation': 'Yokohama City University Medical Center'}}}}