Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 7:19 PM
Study NCT ID:
NCT00370669
Status:
UNKNOWN
Last Update Posted:
2007-02-22
First Post:
2006-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], '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'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2007-02'}, 'lastUpdateSubmitDate': '2007-02-21', 'studyFirstSubmitDate': '2006-08-30', 'studyFirstSubmitQcDate': '2006-08-30', 'lastUpdatePostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity'}, {'measure': 'central macular thickness'}], 'secondaryOutcomes': [{'measure': 'Leakage in fluorescein angiography'}, {'measure': 'intraocular pressure'}, {'measure': 'cataract progression'}, {'measure': 'anterior chamber reaction'}]}, 'conditionsModule': {'keywords': ['Bevacizumab', 'CSME', 'MPC', 'Triamcinolone acetonide'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '22234244', 'type': 'DERIVED', 'citation': 'Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.'}, {'pmid': '19376585', 'type': 'DERIVED', 'citation': 'Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)', 'detailedDescription': 'we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320\n\nExclusion Criteria:\n\n* no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months\n* CVA in past 12 months blood sugar above 250\n* active infection in extraocular adnexa'}, 'identificationModule': {'nctId': 'NCT00370669', 'briefTitle': 'Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8411'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab', 'type': 'DRUG'}, {'name': 'triamcinolone acetonide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Masoud Soheilian, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '+98 21 22585952'}], 'facility': 'Masoud Soheilian', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Masoud Soheilian, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '+98 21 22585952'}], 'overallOfficials': [{'name': 'Masoud Soheilian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Center of Shaheed Beheshti Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}