Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 1:01 PM
Study NCT ID:
NCT01311960
Status:
COMPLETED
Last Update Posted:
2013-04-09
First Post:
2010-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Bevacizumab for Preventing Recurrent Pterygium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-06', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of recurrence after primary pterygium removal', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': '3 months', 'description': 'Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pterygium', 'recurrent pterygium', 'bevacizumab', 'VEGF', 'anti-VEGF'], 'conditions': ['Pterygium', 'Bevacizumab', 'VEGF', 'Anti-VEGF']}, 'referencesModule': {'references': [{'pmid': '26409291', 'type': 'DERIVED', 'citation': 'Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.', 'detailedDescription': 'A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.\n\nThe histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.\n\nWe conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are diagnosed with primary pterygium and plan for pterygium excision with bare sclera by single surgeon. (G.N.)\n* Patients with pterygium who understand and can follow the study protocol.\n* Patients of age more than 30 years\n\nExclusion Criteria:\n\n* Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial wound healing.\n* Patients who are pregnancy or lactation.\n* Patients who have a history of allergy to bevacizumab.\n* Patients who have a history of allergy to steroid eye drops'}, 'identificationModule': {'nctId': 'NCT01311960', 'briefTitle': 'Topical Bevacizumab for Preventing Recurrent Pterygium', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB No. 227/53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bevacizumab eye drop', 'interventionNames': ['Drug: bevacizumab eye drop 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'placebo normal saline eye drop', 'interventionNames': ['Drug: normal saline 0.9%']}], 'interventions': [{'name': 'bevacizumab eye drop 0.05%', 'type': 'DRUG', 'otherNames': ['Study arm'], 'description': 'bevacizumab eye drop 0.05% will apply 4 times a day for 3 months', 'armGroupLabels': ['bevacizumab eye drop']}, {'name': 'normal saline 0.9%', 'type': 'DRUG', 'otherNames': ['placebo arm'], 'description': 'normal saline eye drop 0.9% will apply 4 times a day for 3 months.', 'armGroupLabels': ['placebo normal saline eye drop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathumwan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine, Chulalongkorn university'}], 'overallOfficials': [{'name': 'Ngamjit Kasetsuwan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn Universitiy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Ngamjit Kasetsuwan', 'investigatorAffiliation': 'Chulalongkorn University'}}}}