Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-23 @ 12:21 AM
Study NCT ID:
NCT01744756
Status:
COMPLETED
Last Update Posted:
2012-12-07
First Post:
2012-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subconjunctival Bevacizumab and 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': '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-06', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2012-12-06', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pterygium size after subconjunctival bevacizumab', 'timeFrame': '8 weeks', 'description': '-Size of recurrent pterygium (measured in mm) after injection'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '8 weeks', 'description': '-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subconjunctival Bevacizumab', 'Recurrent pterygium'], 'conditions': ['Recurrent Pterygium']}, 'referencesModule': {'references': [{'pmid': '25076364', 'type': 'DERIVED', 'citation': 'Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.'}]}, 'descriptionModule': {'briefSummary': 'A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.', 'detailedDescription': '1. Pacients with recurrent pterygium\n2. Anti-VEGF therapy -Bevacizumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent pterygium\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History of myocardial infarction\n* History of stroke'}, 'identificationModule': {'nctId': 'NCT01744756', 'acronym': 'BRP', 'briefTitle': 'Subconjunctival Bevacizumab and Recurrent Pterygium', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium', 'orgStudyIdInfo': {'id': 'pterygium bevacizumab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subconjunctival Bevacizumab', 'description': 'One aplication of subconjunctival Bevacizumab 0,5 ml', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'One subconjunctival aplication of Bevacizumabe 0,5ml', 'armGroupLabels': ['Subconjunctival Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74110120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Instituto de Olhos de Goiania', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'Larissa S Stival, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Olhos de Goiania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}