Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT00797992
Status:
COMPLETED
Last Update Posted:
2008-11-25
First Post:
2008-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bevacizumab Intravitreal for Myopic Choroidal Neovascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-24', 'studyFirstSubmitDate': '2008-11-24', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bevacizumab', 'Myopia', 'Complications', 'Neovascularization', 'OCT'], 'conditions': ['Myopic Choroidal Neovascularization']}, 'descriptionModule': {'briefSummary': 'To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).', 'detailedDescription': 'Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myopic CNVM,\n\nExclusion Criteria:\n\n* Patients with poor compliance\n* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\\< one year). (Physician clearance was obtained for all patients).\n* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.\n* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.\n* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.\n* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.\n* Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.'}, 'identificationModule': {'nctId': 'NCT00797992', 'briefTitle': 'Bevacizumab Intravitreal for Myopic Choroidal Neovascularization', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'Bevacizumab Intravitreal for Myopic Choroidal Neovascularization', 'orgStudyIdInfo': {'id': 'JN-05-2008-AR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Myopic eyes with retinal neovascularization', 'interventionNames': ['Drug: Injection']}], 'interventions': [{'name': 'Injection', 'type': 'DRUG', 'description': 'Intravitreal injection of 1.25 mg bevacizumab', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74120-050', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Instituto de Olhos de Goiania', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'Joao J Nassaralla, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Olhos de Goiania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}}}}