Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-25 @ 4:09 AM
Study NCT ID:
NCT00211458
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Age-Related Macular Degeneration'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization following failure of treatment with photodynamic therapy using Visudyne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of patients that previously had a failure of treatment with photodynamic therapy using Visudyne.\n2. Patients must be at least 50 years of age.\n3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart\n4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart\n\nExclusion Criteria:\n\n1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.\n2. Patients who have undergone intraocular surgery within the last 2 months.\n3. Patient participating in any other investigational drug study.\n4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.\n5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).\n6. Patient with significant liver disease or uremia.\n7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.\n8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study\n9. Patient has had insertion of scleral buckle in the study eye\n10. Patient has received radiation treatment\n11. Patient is on anticoagulant therapy with the exception of aspirin\n12. Patient is pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT00211458', 'briefTitle': 'Treatment of Age-Related Macular Degeneration With Anecortave Acetate', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Eye, Ear & Throat Hospital'}, 'officialTitle': 'Treatment of Age-Related Macular Degeneration With Open-label Anecortave Acetate Sterile Suspension (15mg) Following Failed Treatment With Photodynamic Therapy With Visudyne', 'orgStudyIdInfo': {'id': 'Failed PDT treated with AA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anecortave Acetate Sterile Suspension (15 mg)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Eye, Ear & Throat Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jason S Slakter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Eye, Ear & Throat Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Eye, Ear & Throat Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jason Slakter, M.D.', 'investigatorFullName': 'Joan', 'investigatorAffiliation': 'Manhattan Eye, Ear & Throat Hospital'}}}}