Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-03 @ 12:30 AM
Study NCT ID:
NCT00570193
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2007-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic and Pharmacologic Treatment of CNV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-06-06', 'releaseDate': '2013-04-22'}, {'resetDate': '2013-07-16', 'releaseDate': '2013-06-18'}, {'resetDate': '2013-12-12', 'releaseDate': '2013-10-24'}, {'resetDate': '2014-01-27', 'releaseDate': '2013-12-12'}, {'resetDate': '2014-10-29', 'releaseDate': '2014-10-24'}], 'estimatedResultsFirstSubmitDate': '2013-04-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], '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'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077362', 'term': 'Verteporfin'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D011166', 'term': 'Porphyrins'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual change', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Frequency of treatment', 'timeFrame': '18 months'}]}, 'conditionsModule': {'conditions': ['Choroidal Neovascularization', 'Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All previously untreated CNV secondary to MD'}, 'identificationModule': {'nctId': 'NCT00570193', 'acronym': 'PBS', 'briefTitle': 'Photodynamic and Pharmacologic Treatment of CNV', 'organization': {'class': 'OTHER', 'fullName': 'Mid-Atlantic Retina Consultations, Inc.'}, 'officialTitle': 'Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)', 'orgStudyIdInfo': {'id': 'PBS-100-388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)', 'interventionNames': ['Drug: verteporfin (Visudyne)']}, {'type': 'EXPERIMENTAL', 'label': 'II', 'description': 'Treatment with ranibizumab (Lucentis)', 'interventionNames': ['Drug: ranibizumab (Lucentis)']}], 'interventions': [{'name': 'verteporfin (Visudyne)', 'type': 'DRUG', 'otherNames': ['Visudyne = verteporfin', 'Lucentis = ranibizumab'], 'description': 'Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1', 'armGroupLabels': ['I']}, {'name': 'ranibizumab (Lucentis)', 'type': 'DRUG', 'otherNames': ['Lucentis = ranibizumab'], 'description': 'ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\\&37 per study protocol', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nabil M Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mid-Atlantic Retina Consultations'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid-Atlantic Retina Consultations, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-04-22', 'type': 'RELEASE'}, {'date': '2013-06-06', 'type': 'RESET'}, {'date': '2013-06-18', 'type': 'RELEASE'}, {'date': '2013-07-16', 'type': 'RESET'}, {'date': '2013-10-24', 'type': 'RELEASE'}, {'date': '2013-12-12', 'type': 'RESET'}, {'date': '2013-12-12', 'type': 'RELEASE'}, {'date': '2014-01-27', 'type': 'RESET'}, {'date': '2014-10-24', 'type': 'RELEASE'}, {'date': '2014-10-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mid-Atlantic Retina Consultations, Inc.'}}}}