Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT01053858
Status:
COMPLETED
Last Update Posted:
2010-01-22
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058449', 'term': 'Intravitreal Injections'}], 'ancestors': [{'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-20', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': 'baseline, 1 month, 2 months, 3 months, 6 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'central macular thickness by optical coherence tomography', 'timeFrame': 'baseline, 1 month, 2 months, 3 months, 6 months 12months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bevacizumab,triamcinolone, intravitreal injection'], 'conditions': ['Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion\n\nExclusion Criteria:\n\n* previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset\n* Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders\n* neovascularization on the disc or elsewhere or rubeosis'}, 'identificationModule': {'nctId': 'NCT01053858', 'briefTitle': 'Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'orgStudyIdInfo': {'id': '2009_10_12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bevacizumab', 'description': 'intravitreal bevacizumab or triamcinolone determined by single physician', 'interventionNames': ['Procedure: intravitreal injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'triamcinolone', 'interventionNames': ['Procedure: intravitreal injection']}], 'interventions': [{'name': 'intravitreal injection', 'type': 'PROCEDURE', 'description': 'intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection', 'armGroupLabels': ['bevacizumab', 'triamcinolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-060', 'city': 'Chuncheon', 'state': 'anyang', 'country': 'South Korea', 'facility': 'keoung ik Na', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}}}}