Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT01122966
Status:
UNKNOWN
Last Update Posted:
2010-05-26
First Post:
2010-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bevacizumab on the Trabeculectomy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-25', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2010-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraocular pressure', 'timeFrame': 'on postoperative 1month', 'description': 'Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.'}], 'secondaryOutcomes': [{'measure': 'intraocular pressure', 'timeFrame': 'on postoperative 6months, 12months, 18months, 24months', 'description': 'Intraocular pressure is planned to measure when the patient visit the clinic. All intraocular pressure measurements is acquired by glaucoma specialists, using a slitlamp-mounted Goldmann applanation tonometer.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['trabeculectomy'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '19474408', 'type': 'BACKGROUND', 'citation': 'Li Z, Van Bergen T, Van de Veire S, Van de Vel I, Moreau H, Dewerchin M, Maudgal PC, Zeyen T, Spileers W, Moons L, Stalmans I. Inhibition of vascular endothelial growth factor reduces scar formation after glaucoma filtration surgery. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5217-25. doi: 10.1167/iovs.08-2662. Epub 2009 May 27.'}, {'pmid': '18692246', 'type': 'BACKGROUND', 'citation': 'Grewal DS, Jain R, Kumar H, Grewal SP. Evaluation of subconjunctival bevacizumab as an adjunct to trabeculectomy a pilot study. Ophthalmology. 2008 Dec;115(12):2141-2145.e2. doi: 10.1016/j.ophtha.2008.06.009. Epub 2008 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomies with other antimetabolites.', 'detailedDescription': 'Glaucoma filtration surgery is routinely utilized to control intraocular pressure in glaucomatous patients. It reduces IOP by creating a fistula between the anterior chamber and the subconjunctival space with a filtering bleb. Increased wound healing response affects the function and morphology of the filtering bleb, and wound healing involves a series of biological events beginning with hemostasis.\n\nCorticosteroids and antifibrosis agents such as mitomycin C and 5-fluorouracil have been employed in trabeculectomy to delay wound healing and hence to improve the success rate of surgery by inhibiting inflammation and fibroblastic activity, and the use of these antiscarring agents is generally believed to improve the success rate of trabeculectomy.But this rate decreased with passing time and thus was not perfect.\n\nVascular endothelial growth factor is a pivotal stimulator of angiogenesis because its binding to VEGF receptors has been demonstrated to promote endothelial cell migration and proliferation in wound healing.Therefore, anti-VEGF agents may potentially modulate wound healing following glaucoma filtration surgery.\n\nThe principal objective of this study was to evaluate the additive effect of intracameral and subconjunctival injections of bevacizumab in trabeculectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* glaucoma patients who have trabeculectomy\n\nExclusion Criteria:\n\n* patients with the other ocular disease'}, 'identificationModule': {'nctId': 'NCT01122966', 'acronym': 'bevazicumab', 'briefTitle': 'The Effect of Bevacizumab on the Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Effect of Intracameral and Subconjunctival Injections of Bevacizumab in Trabeculectomy With Antimetabolite', 'orgStudyIdInfo': {'id': '2009-01-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'trabeculectomy', 'description': 'Subjects who have trabeculectomies with intraocular bevacizumab injection', 'interventionNames': ['Drug: intraocular injections of bevacizumab']}], 'interventions': [{'name': 'intraocular injections of bevacizumab', 'type': 'DRUG', 'otherNames': ['glaucoma filtering surgery'], 'description': 'intracameral and subconjunctival injections', 'armGroupLabels': ['trabeculectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Changwon Kee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ckee@skku.edu', 'phone': '82-2-3410-3564'}, {'name': 'Wool Suh, M.D.', 'role': 'CONTACT', 'email': 'being111@hotmail.com', 'phone': '82-2-3410-3564'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Changwon Kee, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ckee@skku.edu', 'phone': '82-2-3410-3564'}, {'name': 'Wool Suh, M.D.', 'role': 'CONTACT', 'email': 'being111@hotmail.com', 'phone': '82-2-3410-3564'}], 'overallOfficials': [{'name': 'Changwon Kee, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Changwon Kee', 'oldOrganization': 'Samsung Medical Center'}}}}