Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-04-18 @ 11:46 PM
Study NCT ID:
NCT01166594
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2010-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Bevacizumab in Trabeculectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'catherine.birt@sunnybrook.ca', 'phone': '416 480-5882', 'title': 'Dr Catherine Birt', 'organization': 'Sunnybrook Health Sciences Centre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection - 30 patients', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection - 29 patients', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Other', 'notes': 'Other Adverse events included suprachoroidal hemorrhage, corneal abrasion, hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'Bleb leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders'}, {'term': 'Hypotony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders'}, {'term': 'Choroidal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection - 30 patients'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection - 29 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'One year', 'description': 'Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improved Bleb Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection - 30 patients'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection - 29 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year', 'description': 'Improved bleb appearance was formally graded according to the Indiana bleb-grading scheme at each visit.\n\nThe scheme has 4 sections: height of the bleb (H) with a range of H0 (flat bleb) to H4 (high bleb), horizontal extent of the bleb with a range of E0 (less than 1 clock hour) to E3 (more than 4 clock hours), vascularity of the bleb with a range of V0 (avascular) to V4 (extensive vascularity), and siedel test ranging from S0 (no leak) to S2 (streaming leak within 5 seconds).\n\nEach section was individually scored. Ophthalmic photographs of the surgical site were taken with patient consent. The photographs only included a small portion of the eye and the patient cannot be identified by them.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection - 30 patients'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection - 29 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One year', 'description': 'The number of participants who needed 5-FU injections during the first post-operative year for additional would modulation will be compared between the two groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection - 30 patients'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection - 29 patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab', 'description': 'Tested Drug\n\nBevacizumab: Intrableb injection'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control - BSS\n\nControl: intrableb BSS injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '61.3', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2010-07-19', 'resultsFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-28', 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': 'One year', 'description': 'Intraocular pressure comparison between the two groups at one year following surgery. A window of ±14 days was allowed for the one-year visit'}], 'secondaryOutcomes': [{'measure': 'Improved Bleb Appearance', 'timeFrame': 'One year', 'description': 'Improved bleb appearance was formally graded according to the Indiana bleb-grading scheme at each visit.\n\nThe scheme has 4 sections: height of the bleb (H) with a range of H0 (flat bleb) to H4 (high bleb), horizontal extent of the bleb with a range of E0 (less than 1 clock hour) to E3 (more than 4 clock hours), vascularity of the bleb with a range of V0 (avascular) to V4 (extensive vascularity), and siedel test ranging from S0 (no leak) to S2 (streaming leak within 5 seconds).\n\nEach section was individually scored. Ophthalmic photographs of the surgical site were taken with patient consent. The photographs only included a small portion of the eye and the patient cannot be identified by them.'}, {'measure': 'The Number of Participants Who Received 5-Fluorouracil (5-FU) Injections', 'timeFrame': 'One year', 'description': 'The number of participants who needed 5-FU injections during the first post-operative year for additional would modulation will be compared between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Elevated Intraocular Pressure (IOP)', 'Optic Neuropathy', 'Bleb Failure', 'Avastin (Bevacizumab)'], 'conditions': ['Glaucoma', 'Optic Neuropathy', 'Fibrosis']}, 'descriptionModule': {'briefSummary': 'When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure.\n\nHowever, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.', 'detailedDescription': 'The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years old\n* Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)\n* Decision makers fluent in English\n* Decision makers able to understand and read consent form\n\nExclusion Criteria:\n\n* Patients with active intraocular inflammation/uveitis or neovascular glaucoma\n* History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye\n* Aphakia in surgical eye\n* Pregnant and nursing women\n* Unable to fulfill inclusion criteria\n* Refusal of consent'}, 'identificationModule': {'nctId': 'NCT01166594', 'briefTitle': 'Use of Bevacizumab in Trabeculectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Use of Bevacizumab in Trabeculectomy Surgery. A Prospective, 2 Centre, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '136783'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab', 'description': 'Tested Drug', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control - BSS', 'interventionNames': ['Drug: Control']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Intrableb injection', 'armGroupLabels': ['Bevacizumab']}, {'name': 'Control', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'intrableb BSS injection', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Catherine Birt, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glaucoma Research Society of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Catherine Birt', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}