Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00370851
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2006-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-23', 'studyFirstSubmitDate': '2006-08-31', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'At 12 week'}, {'measure': 'Macular thickness by OCT', 'timeFrame': 'At 12 week'}], 'secondaryOutcomes': [{'measure': 'Need for macular photocuagulation', 'timeFrame': 'At 12th week'}, {'measure': 'Incidence of new vessel formation', 'timeFrame': 'At 12th week'}]}, 'conditionsModule': {'keywords': ['intravitreal Avastin', 'BRVO', 'Macular edema'], 'conditions': ['Retinal Disease']}, 'referencesModule': {'references': [{'pmid': '21337043', 'type': 'DERIVED', 'citation': 'Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE', 'detailedDescription': 'After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with acute BRVO with less than three month duration\n\nExclusion Criteria:\n\n* vision less than 20/320 and vison more than 20/50\n* duration more than 3 months\n* history of glaucoma and diabetic retinopathy\n* any media opacity that prevent funduscopy'}, 'identificationModule': {'nctId': 'NCT00370851', 'briefTitle': 'Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '8532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intravitreal injection of Avastin', 'interventionNames': ['Drug: Avastin (Bevacizumab)']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Avastin (Bevacizumab)']}], 'interventions': [{'name': 'Avastin (Bevacizumab)', 'type': 'DRUG', 'description': 'Intravitreal injection of 125 mg Avastin', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Siamak Moradian, MD', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Siamak Moradian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Center of Shaheed Beheshti Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}