Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 10:17 PM
Study NCT ID:
NCT00797303
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2008-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bevacizumab on Corneal Neovascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016510', 'term': 'Corneal Neovascularization'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2008-11-22', 'studyFirstSubmitQcDate': '2008-11-22', 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of Bevacizumab on Corneal Neovascularization', 'timeFrame': 'Compare the results', 'description': 'Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bevacizumab', 'cornea', 'neovascularization'], 'conditions': ['Corneal Neovascularization']}, 'descriptionModule': {'briefSummary': 'Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.', 'detailedDescription': 'To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) on inflammatory corneal neovascularization.\n\nEight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Corneal Neovascularization\n* Stable lesion\n\nExclusion Criteria:\n\n* Diabetes\n* Autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT00797303', 'acronym': 'BQ-1-08-ARVO', 'briefTitle': 'The Effect of Bevacizumab on Corneal Neovascularization', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'The Effect of Bevacizumab on Corneal Neovascularization', 'orgStudyIdInfo': {'id': 'BQ-1-08-ARVO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'A single intraoperative subconjunctival application of bevacizumab and 2 months follow-up', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Belquiz A Nassaralla, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Olhos de Goiânia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Joao Nassaralla', 'investigatorAffiliation': 'Instituto de Olhos de Goiania'}}}}