Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-04 @ 6:11 PM
Study NCT ID:
NCT00690768
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2008-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D014823', 'term': 'Vitreous Hemorrhage'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005130', 'term': 'Eye Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-03', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of intraoperative intra-ocular bleeding', 'timeFrame': 'three weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Retinal detachment', 'Vitreous Hemorrhage', 'Bevacizumab', 'preoperative', 'pars plana vitrectomy'], 'conditions': ['Diabetic Retinopathy', 'Retinal Detachment']}, 'referencesModule': {'references': [{'pmid': '19208678', 'type': 'DERIVED', 'citation': 'da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. doi: 10.1136/bjo.2008.151233. Epub 2009 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.\n\nExclusion Criteria:\n\n* Massive vitreous hemorrhage preventing from detailed posterior pole examination;\n* Previous intra-ocular surgery other than cataract surgery\n* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin\n* Prothrombin time, partial thromboplastin time or platelet count without normal limits\n* History of previous thromboembolic events'}, 'identificationModule': {'nctId': 'NCT00690768', 'acronym': 'IBETRA', 'briefTitle': 'Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)', 'orgStudyIdInfo': {'id': 'IBETRA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Preoperative Intravitreal bevacizumab and pars plana vitrectomy', 'interventionNames': ['Drug: Bevacizumab', 'Procedure: pars plana vitrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Pars plana vitrectomy only', 'interventionNames': ['Procedure: pars plana vitrectomy']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline', 'armGroupLabels': ['A']}, {'name': 'pars plana vitrectomy', 'type': 'PROCEDURE', 'description': 'pars plana vitrectomy 3 weeks after baseline', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}}}}