Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-29 @ 7:40 AM
Study NCT ID:
NCT00088192
Status:
COMPLETED
Last Update Posted:
2005-08-30
First Post:
2004-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'statusVerifiedDate': '2005-08', 'lastUpdateSubmitDate': '2005-08-29', 'studyFirstSubmitDate': '2004-07-21', 'studyFirstSubmitQcDate': '2004-07-21', 'lastUpdatePostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AMD', 'Age-Related Macular Degeneration', 'Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization'], 'conditions': ['Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.eyetech.com', 'label': 'Sponsors Website'}]}, 'descriptionModule': {'briefSummary': "To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Best corrected visual acuity in the study eye between 20/40 and 20/320.\n* Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \\[including blood, scar/atrophy \\& neovascularization\\] of \\< 12 total disc areas, of which at least 50% must be active CNV.\n* Any subretinal hemorrhage must comprise no more than 50% of total lesion size.\n\nGeneral Criteria:\n\n* Patients of either gender, aged greater than 50 years.\n* Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.\n* Patients who are eligible for PDT with Visudyne\n* Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment."}, 'identificationModule': {'nctId': 'NCT00088192', 'briefTitle': 'Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyetech Pharmaceuticals'}, 'officialTitle': 'An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'EOP1010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pegaptanib sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Doheny Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Retina Consultants, L.L.C.', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Health Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '70155', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Retina Associates', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina Center', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Eye Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Retinal Consultants', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Eye Foundation of Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '03301', 'city': 'Concord', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'The Eye Center of Concord', 'geoPoint': {'lat': 43.20814, 'lon': -71.53757}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Vitreo- Retinal Assoc. of NJ', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Associates of New Jersey, P.A.', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'L.I. Vitreo-Retinal Consultants', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '44107', 'city': 'Lakewood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland Inc.', 'geoPoint': {'lat': 41.48199, 'lon': -81.79819}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean A. McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'The Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29204', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Retina Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Associates, P.A.', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont College of Medicine', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyetech Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}