Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT01342159
Status:
COMPLETED
Last Update Posted:
2011-04-27
First Post:
2011-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-26', 'studyFirstSubmitDate': '2011-04-25', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'baseline, 1 month, 3 months, 6month, 9 month, 12 month'}], 'secondaryOutcomes': [{'measure': 'Central macular thickness', 'timeFrame': 'baseline, 1 month, 3 months, 6 months, 12months', 'description': 'analyzed by optical coherence tomography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bevacizumab, diabetic macular edema, triamcinolone'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'One of the most frequent complications of diabetic retinopathy is diabetic macular edema. Recently, intravitreal bevacizumab and intravitreal triamcinolone were the most popular therapeutic modalities. However, as the long term effects of intravitreal bevacizumab and intravitreal triamcinolone on visual acuity and macular thickness have not been compared, it was the purpose of the present study to compare these treatment effects', 'detailedDescription': 'Randomization of intravitreal bevacizumab, intravitreal triamcinolone, intravitreal bevacizumab with triamcinolone on eyes with diabetic macular edema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic macular edema (central macular thickness greater than 300 mm on optical coherence tomography )\n\nExclusion Criteria:\n\n* history of glaucoma or ocular hypertension (defined as an intraocular pressure higher than 22 mmHg)\n* an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. retinal vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)\n* systemic corticosteroid therapy history of thromboembolic event (including myocardial infarction or cerebral vascular accident)\n* major surgery within the prior 6 months or planned within the next 28 days'}, 'identificationModule': {'nctId': 'NCT01342159', 'briefTitle': 'Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Comparative Treatment of Intravitreal Bevacizumab and Triamcinolone Acetonide on Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'IVBITA'}, 'secondaryIdInfos': [{'id': '20090321', 'type': 'OTHER', 'domain': 'Hallym Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravitreal bevacizumab injection', 'interventionNames': ['Procedure: Intravitreal injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravitreal Triamcinolone injection', 'interventionNames': ['Procedure: Intravitreal injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravitreal bavacizumab with triamcinolone', 'interventionNames': ['Procedure: Intravitreal injection']}], 'interventions': [{'name': 'Intravitreal injection', 'type': 'PROCEDURE', 'description': 'Intravitreal Injections were done under sterile conditions with topical anesthesia and insertion of a lid speculum. For the bevacizumab group, 1.25 mg (0.05 cc) bevacizumab (Avastin, made for F. Hoffmann-La Roche Ltd Basel, Switzerland by Genentech Inc., San Francisco, CA, USA) was injected intravitreally with a 30-gauge needle through the superotemporal quadrant. For the bevacizumab with triamcinolone group, in addition to intravitreal bevacizumab, 2 mg(0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally through the inferotemporal quadrant. For triamcinolone group, 2 mg (0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally.', 'armGroupLabels': ['Intravitreal Triamcinolone injection', 'Intravitreal bevacizumab injection', 'intravitreal bavacizumab with triamcinolone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'JiWon Lim', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hallym Medical Center', 'oldOrganization': 'Hallym Medical Center'}}}}