Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-02 @ 10:11 PM
Study NCT ID:
NCT02033018
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2013-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aflibercept Intravitreal Injection 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': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2013-12-31', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.', 'description': '8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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. AII 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 1 year.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.', 'description': '8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aflibercept', 'Myopia', 'Complications', 'Neovascularization', 'OCT'], 'conditions': ['Choroidal Retinal Neovascularization']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary', 'detailedDescription': 'Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 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 and 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': 'NCT02033018', 'acronym': 'AflibxMyopia', 'briefTitle': 'Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Olhos de Goiania'}, 'officialTitle': 'Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization', 'orgStudyIdInfo': {'id': 'JJ - 3/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aflibercept injection', 'description': 'Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection', 'interventionNames': ['Drug: Aflibercept Injection']}], 'interventions': [{'name': 'Aflibercept Injection', 'type': 'DRUG', 'otherNames': ['Aflibercept intravitreal injection of 0,5 mg ( 0.05mL'], 'description': 'Aflibercept intravitreal injection', 'armGroupLabels': ['Aflibercept injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74120-050', 'city': 'Goiânia', 'state': 'Goiás', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Brazil', 'facility': 'Instituto de Olhos de Goiania', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '74120-050', 'city': 'Goiânia', 'state': 'Goiás', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Raquel Monteiro', 'role': 'CONTACT', 'phone': '55 62 3220 2511'}, {'name': 'João J Nassaralla, JR', 'role': 'CONTACT', 'email': 'nassaral@terra.com.br', 'phone': '55 62 3220 2545'}, {'name': 'Joao J Nassaralla, Jr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Olhos de Goiania', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'centralContacts': [{'name': 'Raquel Monteiro', 'role': 'CONTACT', 'phone': '55 62 3220 2500'}, {'name': 'João J Nassaralla, Jr', 'role': 'CONTACT', 'email': 'nassaral@terra.com.br', 'phone': '55 62 3220 2545'}], 'overallOfficials': [{'name': 'Joao J Nassaralla, Jr', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Olhos de Goiânia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Olhos de Goiania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}