Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 6:48 PM
Study NCT ID:
NCT01025934
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2009-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Proliferative Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '20135139', 'type': 'DERIVED', 'citation': 'di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):785-91. doi: 10.1007/s00417-010-1303-3. Epub 2010 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* vitreous haemorrhage\n* tractional retinal detachment\n* active proliferative diabetic retinopathy.\n\nExclusion Criteria:\n\n* neovascular glaucoma\n* cataract\n* combined traction and rhegmatogenous RD'}, 'identificationModule': {'nctId': 'NCT01025934', 'briefTitle': 'Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'IVBDRNA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '7 days', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '20 days', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham', 'interventionNames': ['Other: sham']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'armGroupLabels': ['20 days', '7 days']}, {'name': 'sham', 'type': 'OTHER', 'armGroupLabels': ['sham']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Napoli CTO Hospital', 'class': 'UNKNOWN'}]}}}