Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT01014468
Status:
UNKNOWN
Last Update Posted:
2011-11-22
First Post:
2009-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D058449', 'term': 'Intravitreal Injections'}, {'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'}, {'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-19', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Ocular side effects (infection, RD, IOP rise, cataract)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ranibizumab', 'bevacizumab', 'AMD', 'Complications', 'Visual acuity', 'OCt', 'Age Macular Degeneration'], 'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.', 'detailedDescription': 'We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 years\n* Active primary or recurrent subfoveal lesion with CNV secondary to AMD\n\nExclusion Criteria:\n\n* Prior treatment with any intravitreal drug in the study eye\n* Prior treatment with verteporfin photodynamic therapy in the study eye\n* Prior treatment with systemic bevacizumab\n* Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry\n* Laser photocoagulation within 1 month before study entry in the study eye\n* Previous participation in any clinical trial within 1 month before the entry of the study\n* Subfoveal fibrosis or atrophy in the study eye\n* CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia\n* Retinal pigment epithelial tear involving the macula in the study eye\n* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.\n* Active intraocular inflammation\n* Vitreous hemorrhage in the study eye'}, 'identificationModule': {'nctId': 'NCT01014468', 'acronym': 'AxL-2009', 'briefTitle': 'Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'JJNJ - 8 - 2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab', 'description': 'Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)', 'interventionNames': ['Drug: Ranibizumab (Intravitreal injection)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab', 'description': 'Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)', 'interventionNames': ['Drug: Bevacizumab (Intravitreal injection)']}], 'interventions': [{'name': 'Ranibizumab (Intravitreal injection)', 'type': 'DRUG', 'description': 'Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly', 'armGroupLabels': ['Ranibizumab']}, {'name': 'Bevacizumab (Intravitreal injection)', 'type': 'DRUG', 'description': 'Intravitreal injection of Ranibizumab 0.5 mg or Bevacizumab 1.25 mg (3 monthly injection followed by monthly', 'armGroupLabels': ['Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Instituto de Olhos de Goiânia', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'João J Nassaralla, Jr', 'role': 'STUDY_CHAIR', 'affiliation': 'IOG and UnB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Joao Nassaralla', 'investigatorAffiliation': 'Instituto de Olhos de Goiania'}}}}