Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01229202
Status:
WITHDRAWN
Last Update Posted:
2024-08-21
First Post:
2010-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No REB file', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post surgery IOP (Intra Ocular Pressure Measurement)', 'timeFrame': 'one year post surgery'}], 'secondaryOutcomes': [{'measure': 'bleb appearance', 'timeFrame': 'one year post surgery'}, {'measure': 'number of bleb needlings', 'timeFrame': 'one year post surgery'}, {'measure': 'number of glaucoma medications at 12 months postoperatively', 'timeFrame': 'one year post surgery'}, {'measure': 'eye complications', 'timeFrame': 'one year post surgery'}, {'measure': 'systemic complications', 'timeFrame': 'one year post surgery'}, {'measure': 'need for another glaucoma surgery to control glaucoma', 'timeFrame': 'one year post surgery'}, {'measure': 'postoperative visual acuity at 12 months', 'timeFrame': '12 months post surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['trabeculectomy', 'glaucoma surgery', 'bevacizumab', 'Vascular Endothelial Growth Inhibitor', 'glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "Vascular epithelial growth factor (VEGF) plays a critical role in vessel growth and wound healing. Bevacizumab, a non specific VEGF inhibitor, has been successfully used for the treatment of eye diseases associated with neovascularization. The purpose of this randomized study is 1) to investigate the effects of intraoperative subtenon injection of bevacizumab on the outcomes of trabeculectomy surgery. 2) to measure plasma and aqueous levels of VEGF and assess its association with the outcomes of trabeculectomy surgery. Trabeculectomy surgery, where a small drainage canal is created at the front of the eye, is the most common glaucoma surgery performed worldwide. The goal of the surgery is to control intraocular pressure. Failure of this procedure is most commonly caused by excessive scarring of the surgical site. If scarring occurs, the drainage canal can close. By adding Bevacizumab at the time of surgery, wound healing may be slowed and surgical failure prevented.\n\nThe results of this study will be helpful in the future development of new more effective and safe surgical techniques for treatment of glaucoma.\n\nPatients who have given informed consent are randomized into two groups. One group receives standard of care for trabeculectomy surgery and the other group receives standard of care plus an injection of Bevacizumab at the surgery site. Both groups have a one time collection of ocular fluid and a blood sample taken from a vein in the arm. After surgery, patients are seen by their study doctor six times in the following year. At these visits measurements are taken of their visual acuity, eye pressure and blood pressure. The doctor does a clinical exam and at months six and twelve photographs of the patients' eye are taken."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any type of glaucoma, except neovascular or inflammatory\n* patients requiring trabeculectomy or combined cataract surgery with trabeculectomy surgery\n\nExclusion Criteria:\n\n* younger than 30 years of age\n* previous ocular surgeries excepting cataract surgeries\n* patients who have had or present with intraocular inflammation\n* neovascular glaucoma\n* patients who are aphakic\n* diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT01229202', 'briefTitle': 'Use of Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Use of Vascular Endothelial Growth Factor Inhibitor, Bevacizumab to Modulate the Outcomes of Trabeculectomy Surgery', 'orgStudyIdInfo': {'id': 'CD-2007-331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care', 'description': 'standard of care for trabeculectomy surgery', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bevacizumab arm', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery', 'armGroupLabels': ['bevacizumab arm', 'standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'CDHA', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Lesya Shuba, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CDHA Halifax Nova Scotia Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}