Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT00801866
Status:
WITHDRAWN
Last Update Posted:
2024-05-30
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avastin for Post-photocoagulation Macular Edema
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': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'undefined', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity'}], 'secondaryOutcomes': [{'measure': 'Central Retinal Thickness.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Panretinal Photocoagulation', 'Macular Edema', 'Intravitreal Bevacizumab'], 'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Proliferative retinopathy or severe non-proliferative retinopathy\n* BCVA of 20/63 or better (56 ETDRS letters\n* No history of Macular Edema\n* Central Retinal Thickness of 250mics or more\n\nExclusion Criteria:\n\n* Previous treatment.\n* Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy\n* Media opacities'}, 'identificationModule': {'nctId': 'NCT00801866', 'briefTitle': 'Avastin for Post-photocoagulation Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Prevention of Post-photocoagulation Macular Edema by Intravitreal Bevacizumab.', 'orgStudyIdInfo': {'id': 'APEC-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Panretinal Photocoagulation + Bevacizumab', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Panretinal Photocoagulation', 'interventionNames': ['Procedure: Panretinal Photocoagulation']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Intravitreal administration', 'armGroupLabels': ['Group 1']}, {'name': 'Panretinal Photocoagulation', 'type': 'PROCEDURE', 'description': 'Panretinal Photocoagulation', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Eduarto Torres-Porras, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Octavio Burgos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}