Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT02321267
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2014-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of the Clinical Course of Macular Diseases in Kagawa
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': 'C533178', 'term': 'aflibercept'}, {'id': 'C495058', 'term': 'pegaptanib'}, {'id': 'D000077362', 'term': 'Verteporfin'}], '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': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of best-collected visual acuity from baseline at 5 years', 'timeFrame': 'Five years after the registration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AMD', 'PCV', 'RAP', 'RVO', 'DME', 'ERM', 'MH', 'mCNV'], 'conditions': ['Macular Disease']}, 'descriptionModule': {'briefSummary': 'Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).\n\nPatients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS.\n* Patients who are agreed with the participation of this study.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02321267', 'briefTitle': 'Cohort Study of the Clinical Course of Macular Diseases in Kagawa', 'organization': {'class': 'OTHER', 'fullName': 'Kagawa University'}, 'officialTitle': 'Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)', 'orgStudyIdInfo': {'id': 'H26-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Macular disease with adequate treatments', 'description': 'Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.', 'interventionNames': ['Drug: ranibizumab, aflibercept, pegaptanib, verteporphin']}], 'interventions': [{'name': 'ranibizumab, aflibercept, pegaptanib, verteporphin', 'type': 'DRUG', 'otherNames': ['Lucentis, Eylea, Macugen, Vizudyne'], 'description': 'ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡', 'armGroupLabels': ['Macular disease with adequate treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '761-0793', 'city': 'Hiragi', 'state': 'Kagawa-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'chosa@med.kagawa-u.ac.jp', 'phone': '+81878912211'}], 'facility': 'Kagawa University Faculty of Medicine', 'geoPoint': {'lat': 34.2706, 'lon': 134.13074}}], 'centralContacts': [{'name': 'Chika Akuta', 'role': 'CONTACT', 'email': 'kaomie@med.kagawa-u.ac.jp', 'phone': '+81-87-891-2211'}], 'overallOfficials': [{'name': 'Akiataka Tsujikawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kagawa Univerisity Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kagawa University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman', 'investigatorFullName': 'Akitaka Tsujikawa', 'investigatorAffiliation': 'Kagawa University'}}}}