Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-09 @ 3:23 PM
Study NCT ID:
NCT00150202
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Of EYE001 For Wet-Type AMD (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': 'C495058', 'term': 'pegaptanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-04', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.'}], 'secondaryOutcomes': [{'measure': 'Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.'}]}, 'conditionsModule': {'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Wet AMD, Visual Acuity from 20/320 to 20/40\n\nExclusion Criteria:\n\n* Diabetic retinopathy, laser coagulation history'}, 'identificationModule': {'nctId': 'NCT00150202', 'briefTitle': 'Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'A5751010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pegaptanib sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '279-0021', 'city': 'Urayasu-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Tokyo', 'state': 'Chiyoda-ku', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960-1295', 'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '371-8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '060-8604', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '761-0793', 'city': 'Kida-gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '570-8506', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '520-2192', 'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}