Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-01-17 @ 3:52 AM
Study NCT ID:
NCT00566761
Status:
TERMINATED
Last Update Posted:
2024-05-30
First Post:
2007-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D014221', 'term': 'Triamcinolone'}], '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'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'undefined', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2007-11-30', 'studyFirstSubmitQcDate': '2007-11-30', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Best corrected visual acuity and macular edema measured with OCT', 'timeFrame': 'Follow up to 3 , 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Report treatment complications', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Macular edema', 'central retinal vein occlusion', 'bevacizumab', 'triamcinolone'], 'conditions': ['Macular Edema', 'Central Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.', 'detailedDescription': 'Comparison of two groups with different treatment with registrations of outcome in BCVA and complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Macular edema secondary to central retinal vein occlusion\n* BCVA worse than 20/40\n* Central macular \\>250 mc with OCT\n\nExclusion Criteria:\n\n* Diabetic retinopathy or other retinopathy\n* Media opacity that does not allow following\n* steroid responder\n* diagnosed glaucoma or IOP \\> 21 mmHg'}, 'identificationModule': {'nctId': 'NCT00566761', 'acronym': 'MECROV', 'briefTitle': 'Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'MECRVO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab and triamcinolone', 'type': 'DRUG', 'description': 'three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Coyoacan', 'country': 'Mexico', 'facility': 'Asociacion Para Evitar la Ceguera en Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Carmen Gonzalez-Mijares, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Hugo Quiroz-Mercado, Retinologyst', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Juan Manuel Jimenez Sierra, Retinologyst', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'MA Martinez-Castellanos, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Octavio Burgos Vejar, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Raul Velez-Montoya, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Ma de Lourdes Lopez Ramos, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}, {'name': 'Omar Honerlager, preresident', 'role': 'STUDY_CHAIR', 'affiliation': 'Asociación para Evitar la Ceguera en México'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carmen Cecilia Gonzalez Mijares', 'oldOrganization': 'Asociación para Evitar la Ceguera en Mexico IAP'}}}}