Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-08 @ 6:38 PM
Study NCT ID:
NCT01108250
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
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': 'D005838', 'term': 'Genotype'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-28', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-04-20', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genotyping of LOC387715/HTRA1 of PCV and control groups', 'timeFrame': '4weeks', 'description': 'to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy (PCV)'}], 'secondaryOutcomes': [{'measure': 'Indocyanine angiographic findings of polypoidal choroidal vasculopathy', 'timeFrame': '20 minutes', 'description': 'The association of the risk allele of the LOC387715/HTRA1 and indocyanine angiographic characteristics of polypoidal choroidal vasculopathy including subretinal hemorrhage, pigment epithelial detachment, and serous retinal detachment.'}, {'measure': 'Visual acuity using Snellen chart', 'timeFrame': '2 x 5 minutes', 'description': 'To evaluate the association between visual acuity and genotype of polypoidal choroidal vasculopathy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '19268887', 'type': 'BACKGROUND', 'citation': 'Gotoh N, Nakanishi H, Hayashi H, Yamada R, Otani A, Tsujikawa A, Yamashiro K, Tamura H, Saito M, Saito K, Iida T, Matsuda F, Yoshimura N. ARMS2 (LOC387715) variants in Japanese patients with exudative age-related macular degeneration and polypoidal choroidal vasculopathy. Am J Ophthalmol. 2009 Jun;147(6):1037-41, 1041.e1-2. doi: 10.1016/j.ajo.2008.12.036. Epub 2009 Mar 9.'}], 'seeAlsoLinks': [{'url': 'http://ghr.nlm.nih.gov/', 'label': 'genetics home reference'}, {'url': 'http://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v:project=medlineplus&query=loc387715', 'label': 'MedlinePlus related topics'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy and whether they are associated with clinical patterns including angiographic phenotype in a Korean population.', 'detailedDescription': 'This is a cross-sectional case-control study. One hundred Korean patients with polypoidal choroidal vasculopathy and 100 control subjects were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Polypoidal choroidal vasculopathy group\n\nInclusion Criteria:\n\n* patients older than 60 years of age at onset\n* polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography and subretinal reddish-orange protrusions corresponding to polyp-like lesions\n\nExclusion Criteria:\n\n* eyes with pathologic myopia, angioid streaks, central serous chorioretinopathy, and other retinal or choroidal diseases\n\nControl group\n\nInclusion Criteria:\n\n* individuals without retinal diseases and without any signs of polypoidal choroidal vasculopathy or age-related macular degeneration on the bases of comprehensive ophthalmic examination results'}, 'identificationModule': {'nctId': 'NCT01108250', 'acronym': 'PCV', 'briefTitle': 'LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population', 'orgStudyIdInfo': {'id': 'LOC387715/HTRA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'polypoidal choroidal vasculopathy', 'description': 'patients with polypoidal choroidal vasculopathy', 'interventionNames': ['Genetic: LOC387715/HTRA1 genotyping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'control group with no polypoidal choroidal vasculopathy', 'interventionNames': ['Genetic: LOC387715/HTRA1 genotyping']}], 'interventions': [{'name': 'LOC387715/HTRA1 genotyping', 'type': 'GENETIC', 'otherNames': ['genotyping'], 'description': 'Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.', 'armGroupLabels': ['control', 'polypoidal choroidal vasculopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'state': 'Kyungsangpookdo', 'country': 'South Korea', 'facility': 'In Taek Kim', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'In Taek Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Dong Ho Park', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}