Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00312351
Status:
TERMINATED
Last Update Posted:
2007-01-15
First Post:
2006-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet 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': 'C495058', 'term': 'pegaptanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 262}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2007-01-12', 'studyFirstSubmitDate': '2006-04-06', 'studyFirstSubmitQcDate': '2006-04-07', 'lastUpdatePostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AMD', 'Age-Related Macular Degeneration', 'Macular Degeneration', 'Macugen', 'pegaptanib sodium', 'ERG', 'specular microscopy', 'Age-Related Mcular Degeneration (AMD)'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.'}, '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.\n* Best corrected visual acuity in the study eye between 20/40 and 20/320.\n* Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.\n\nExclusion Criteria:\n\n* Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.'}, 'identificationModule': {'nctId': 'NCT00312351', 'briefTitle': 'A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyetech Pharmaceuticals'}, 'officialTitle': 'An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'EOP1014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pegaptanib sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye, Ear, Nose and Throat Associates, P.A.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyetech Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}