Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT00134667
Status:
TERMINATED
Last Update Posted:
2007-01-15
First Post:
2005-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
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': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'C008848', 'term': '1-phenyl-3,3-dimethyltriazene'}, {'id': 'D000077362', 'term': 'Verteporfin'}, {'id': 'C495058', 'term': 'pegaptanib'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 360}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-03'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2008-10'}, 'lastUpdateSubmitDate': '2007-01-12', 'studyFirstSubmitDate': '2005-08-24', 'studyFirstSubmitQcDate': '2005-08-24', 'lastUpdatePostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AMD', 'Age-Related Macular Degeneration', 'Macular Degeneration', 'Macugen', 'Photodynamic Therapy', 'PDT', 'Visudyne', 'pegaptanib sodium', 'verteporfin', 'Predominantly Classic', 'Age-Related Macular Degeneration (AMD)'], 'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of either gender; aged 50 years or greater.\n* Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition\n* Best corrected visual acuity in the study eye between 20/40 and 20/200\n\nExclusion Criteria:\n\n* Any prior PDT with Visudyne to the study eye\n* Any previous AMD thermal laser therapy to the study eye'}, 'identificationModule': {'nctId': 'NCT00134667', 'briefTitle': 'Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyetech Pharmaceuticals'}, 'officialTitle': 'A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'EOP1012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Photodynamic Therapy (PDT) with Visudyne (verteporfin)', 'type': 'DRUG'}, {'name': 'Macugen (pegaptanib sodium)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704-5614', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Centers, P.C., Northwest Location', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyetech Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}