Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT00804206
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central macular thickness', 'timeFrame': 'baseline, 10 days, 52 days, 85 days'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'baseline, 10 days, 52 days, 85 days'}]}, 'conditionsModule': {'keywords': ['Intravitreal injection of Bevacizumab', 'Visual acuity', 'central retinal thickness', 'color studies, Farnsworth-Munsell', 'electroretinogram studies'], 'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with proliferative diabetic retinopathy\n* patients with macular edema\n\nExclusion Criteria:\n\n* patients with previous treatments\n* patients with ocular surgeries'}, 'identificationModule': {'nctId': 'NCT00804206', 'briefTitle': 'Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation', 'orgStudyIdInfo': {'id': 'APEC-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Bevacizumab before panretinal photocoagulation.', 'interventionNames': ['Drug: bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Bevacizumab after panretinal photocoagulation', 'interventionNames': ['Drug: bevacizumab']}], 'interventions': [{'name': 'bevacizumab', 'type': 'DRUG', 'description': 'Intravitreal bevacizumab before panretinal photocoagulation', 'armGroupLabels': ['Group A']}, {'name': 'bevacizumab', 'type': 'DRUG', 'description': 'Intravitreal Bevacizumab after panretinal photocoagulation', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'México', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}