Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-08 @ 9:20 AM
Study NCT ID:
NCT02310295
Status:
COMPLETED
Last Update Posted:
2014-12-08
First Post:
2014-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-03-02', 'releaseDate': '2021-02-09'}], 'estimatedResultsFirstSubmitDate': '2021-02-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'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': 'D014221', 'term': 'Triamcinolone'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central subfield macular thickness', 'timeFrame': '12 months', 'description': 'retinal thickness measured with optical coherence tomography'}, {'measure': 'Visual acuity', 'timeFrame': '12 months', 'description': 'Best corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic retinopathy', 'Macular edema', 'Anti-VEGF', 'Triamcinolone'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination\n2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)\n3. signed of inform Consent.\n\nExclusion Criteria:\n\n1. HbA1c levels greater than 10%\n2. thromboembolic event history (including myocardial infarction and stroke)\n3. vitreo-macular traction on OCT\n4. coagulation disorders\n5. macular ischemia on fluorescein angiography examination\n6. proliferative diabetic retinopathy that required treatment\n7. eye surgery\n8. history of ocular hypertension or glaucoma\n9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)\n10. systemic corticosteroid therapy\n11. any conditions that could affect the documentation\n12. any previous treatment for diabetic macular edema.'}, 'identificationModule': {'nctId': 'NCT02310295', 'acronym': 'IBeTA', 'briefTitle': 'Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)', 'orgStudyIdInfo': {'id': '12029-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IVB-Laser', 'description': 'Intravitreal Bevacizumab combined with focal laser therapy', 'interventionNames': ['Device: Laser', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVTA-Laser', 'description': 'Intravitreal Triamcinolone combined with focal laser therapy', 'interventionNames': ['Device: Laser', 'Drug: Triamcinolone Acetonide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser', 'description': 'focal laser therapy', 'interventionNames': ['Device: Laser']}], 'interventions': [{'name': 'Laser', 'type': 'DEVICE', 'description': 'focal macular laser therapy', 'armGroupLabels': ['IVB-Laser', 'IVTA-Laser', 'Laser']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Intravitreal injection of Bevacizumab', 'armGroupLabels': ['IVB-Laser']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Intravitreal injection of Triamcinolone Acetonide', 'armGroupLabels': ['IVTA-Laser']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Andre Messias', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-02-09', 'type': 'RELEASE'}, {'date': '2021-03-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Andre Messias, PhD, University of Sao Paulo'}}}}