Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT00467935
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2007-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scotoma Reduction in AMD Patients Treated With Ranibizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D006009', 'term': 'Glycogen Storage Disease Type II'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D012607', 'term': 'Scotoma'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006008', 'term': 'Glycogen Storage Disease'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': '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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-28', 'studyFirstSubmitDate': '2007-04-29', 'studyFirstSubmitQcDate': '2007-04-30', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scotoma reduction', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'improved visual function', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amd', 'disciform', 'fibrosis', 'Lucentis', 'scotoma'], 'conditions': ['Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.retinaresearchfoundation.org', 'label': 'Sponsor'}, {'url': 'http://retinaconsultants.org', 'label': 'sponsor'}]}, 'descriptionModule': {'briefSummary': 'This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.', 'detailedDescription': 'Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BCVA \\< 20/320\n* Disciform macular degeneration wiht exudation\n\nExclusion Criteria:\n\n* Non-amd CNV'}, 'identificationModule': {'nctId': 'NCT00467935', 'acronym': 'SALVAGE', 'briefTitle': 'Scotoma Reduction in AMD Patients Treated With Ranibizumab', 'organization': {'class': 'OTHER', 'fullName': 'Retina Research Foundation'}, 'officialTitle': 'A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis', 'orgStudyIdInfo': {'id': 'FVF3933'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intravitreal injection Lucentis (ranibizumab)', 'type': 'DRUG', 'description': 'intravitreal injection Lucentis (ranibizumab)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Retina Research Center', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}], 'overallOfficials': [{'name': 'Paul M Beer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paul Beer, MD', 'oldOrganization': 'Retina Consultants, PLLC'}}}}