Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 12:01 PM
Study NCT ID:
NCT00395551
Status:
COMPLETED
Last Update Posted:
2010-01-08
First Post:
2006-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-07', 'studyFirstSubmitDate': '2006-11-01', 'studyFirstSubmitQcDate': '2006-11-02', 'lastUpdatePostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measures for safety and tolerability', 'timeFrame': 'Mean change in visual acuity from baseline to 6 months & 12 months'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome measures for efficacy', 'timeFrame': 'Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['choroidal neovascularization', 'Choroidal Neovascularization Not related to Age-Related Macular Degeneration'], 'conditions': ['Choroidal Neovascularization']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* active choroidal neovascularization\n\nExclusion Criteria:\n\n* pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies'}, 'identificationModule': {'nctId': 'NCT00395551', 'briefTitle': 'Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.', 'organization': {'class': 'OTHER', 'fullName': 'Ophthalmic Consultants of Boston'}, 'officialTitle': 'A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.', 'orgStudyIdInfo': {'id': 'FVF 3688 Non-AMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ranibizumab', 'description': 'ranibizumab 0.5mg intravitreal injection', 'interventionNames': ['Drug: ranibizumab']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'description': '0.5mg intravitreal injection', 'armGroupLabels': ['ranibizumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeffrey S Heier, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ophthalmic Consultants of Boston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Jeffrey S. Heier', 'oldOrganization': 'Ophthalmic Consultants of Boston'}}}}