Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 10:36 AM
Study NCT ID:
NCT00288561
Status:
COMPLETED
Last Update Posted:
2008-06-19
First Post:
2006-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and 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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-18', 'studyFirstSubmitDate': '2006-02-07', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ARMD, ranibizumab, verteporfin'], 'conditions': ['Age-Related Macular Degeneration (ARMD)']}, 'descriptionModule': {'briefSummary': 'Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 50 years of age or greater who have provided written informed consent\n\n * Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component\n * Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)\n * Willing to return for all scheduled visits\n\nExclusion Criteria:\n\n* \\- Patients who have a BCVA of \\< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)\n* Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy\n* Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00288561', 'briefTitle': 'Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)', 'orgStudyIdInfo': {'id': 'CRFB002B2201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ranibizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Customer Information', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis - Including Sites in Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}