Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-13 @ 1:05 PM
Study NCT ID:
NCT00504959
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2007-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2007-07-19', 'studyFirstSubmitQcDate': '2007-07-19', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml)'}], 'secondaryOutcomes': [{'measure': 'Efficacy assessed by mean change in BCVA from Baseline at M 6, 12, 18, and 24. Number of injections with ranibizumab. Safety assessed by AEs and SAEs leading to premature discont. of study drug, vital signs, and ophthalmic exams.'}]}, 'conditionsModule': {'keywords': ['Age-related macular degeneration (AMD),', 'choroidal neovascularization (CNV),', 'vascular endothelial growth factor (VEGF)'], 'conditions': ['Subfoveal Choroidal Neovascularization (CNV)', 'Secondary to Age-related Macular Degeneration (AMD)']}, 'referencesModule': {'references': [{'pmid': '23021093', 'type': 'DERIVED', 'citation': 'Silva R, Axer-Siegel R, Eldem B, Guymer R, Kirchhof B, Papp A, Seres A, Gekkieva M, Nieweg A, Pilz S; SECURE Study Group. The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):130-9. doi: 10.1016/j.ophtha.2012.07.026. Epub 2012 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303\n\nExclusion Criteria:\n\n* Concurrent participation in another clinical trial, i.e. use of other investigational drugs'}, 'identificationModule': {'nctId': 'NCT00504959', 'briefTitle': 'Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IV, Long-term, Open-label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'CRFB002A2402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ranibizumab', 'interventionNames': ['Drug: ranibizumab']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['rhuFab V2, Lucentis'], 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'country': 'Australia', 'facility': 'Novartis Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Laken', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87585, 'lon': 4.34844}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 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'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative SIte', 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