Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:47 PM
Study NCT ID:
NCT00804934
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in visual acuity at 6 and 12 months', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Wet AMD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.', 'detailedDescription': 'To determine mean change in visual acuity at 6 and 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study\n* Age greater then and equal 50 years\n* Patients with active neovascular AMD\n* Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months\n* If the patient has bilateral disease and qualifies for the study, both eyes may be included\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from this study:\n* Pregnancy or lactation\n* Premenopausal women not using adequate contraception.\n* Participation in another simultaneous medical investigation'}, 'identificationModule': {'nctId': 'NCT00804934', 'briefTitle': 'Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis', 'organization': {'class': 'OTHER', 'fullName': 'Retina Institute of Hawaii'}, 'officialTitle': 'Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months', 'orgStudyIdInfo': {'id': 'F4421S'}}, 'armsInterventionsModule': {'armGroups': [{'label': '0', 'interventionNames': ['Drug: Lucentis']}], 'interventions': [{'name': 'Lucentis', 'type': 'DRUG', 'description': '0.5mg Lucentis every four months', 'armGroupLabels': ['0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96815', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Retina Institute of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Debra L Shimabukuro, RN', 'role': 'STUDY_CHAIR', 'affiliation': 'Retina Institute of Hawaii'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Institute of Hawaii', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}