Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-26 @ 10:03 AM
Study NCT ID:
NCT00801450
Status:
UNKNOWN
Last Update Posted:
2009-10-12
First Post:
2008-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-08', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2009-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'central subfield macular thickness', 'timeFrame': 'baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity', 'timeFrame': 'baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively'}, {'measure': 'Intraocular pressure', 'timeFrame': 'baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'macular edema', 'triamcinolone', 'cataract', 'refractory diabetic macular edema'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '19027427', 'type': 'BACKGROUND', 'citation': 'Kumar V, Ghosh B, Raina UK, Goel N. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 Dec;146(6):974; author reply 974-5. doi: 10.1016/j.ajo.2008.08.013. No abstract available.'}, {'pmid': '16978576', 'type': 'BACKGROUND', 'citation': 'Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.'}, {'pmid': '16186372', 'type': 'BACKGROUND', 'citation': "Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297."}, {'pmid': '17965109', 'type': 'BACKGROUND', 'citation': 'Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.'}]}, 'descriptionModule': {'briefSummary': "Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory diffuse DME unresponsive to focal laser photocoagulation\n* Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm\n\nExclusion Criteria:\n\n* Previous ocular surgery\n* Glycosylated hemoglobin (Hb A1C) rate above 10%\n* History of glaucoma or ocular hypertension\n* Loss of vision as a result of other causes\n* Systemic corticoid therapy\n* Severe systemic disease\n* Any condition affecting follow-up or documentation'}, 'identificationModule': {'nctId': 'NCT00801450', 'briefTitle': "Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery", 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': '2995/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal (IVI)', 'interventionNames': ['Drug: Triamcinolone acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'SubTenon´s (STI)', 'interventionNames': ['Drug: Triamcinolone acetonide']}], 'interventions': [{'name': 'Triamcinolone acetonide', 'type': 'DRUG', 'description': '4 mg', 'armGroupLabels': ['Intravitreal (IVI)']}, {'name': 'Triamcinolone acetonide', 'type': 'DRUG', 'description': '40 mg', 'armGroupLabels': ['SubTenon´s (STI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Rodrigo Jorge', 'oldOrganization': 'University of São Paulo'}}}}