Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-28 @ 5:30 PM
Study NCT ID:
NCT01201161
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranibizumab for Diabetic Traction Retinal Detachment
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': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-13', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of intraoperative intra-ocular bleeding', 'timeFrame': 'one week', 'description': 'amount of intra-ocular bleeding that occurred during pars plana vitrectomy'}], 'secondaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': '12 weeks', 'description': 'ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Retinal detachment', 'Vitreous Hemorrhage', 'Preoperative Ranibizumab', 'pars plana vitrectomy'], 'conditions': ['Diabetic Retinopathy', 'Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.'}, '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': 'NCT01201161', 'acronym': 'RANITRA', 'briefTitle': 'Ranibizumab for Diabetic Traction Retinal Detachment', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment', 'orgStudyIdInfo': {'id': 'RANITRA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RANI/PPV', 'description': 'Preoperative intravitreal ranibizumab and pars plana vitrectomy', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PPV', 'description': 'Sham injection and pars plana vitrectomy', 'interventionNames': ['Other: Sham injection']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy', 'armGroupLabels': ['RANI/PPV']}, {'name': 'Sham injection', 'type': 'OTHER', 'description': 'Simulation of intravitreal injection one week before pars plana vitrectomy', 'armGroupLabels': ['PPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Rodrigo Jorge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}}}}