Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT00211432
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-04', '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': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pseudovitellium Detachment', 'Eye Diseases']}, '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 pseudovitelliform detachment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of patients with pseudovitellium detachment.\n2. Patients must be at least 18 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': 'NCT00211432', 'briefTitle': 'Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Eye, Ear & Throat Hospital'}, 'orgStudyIdInfo': {'id': 'Pseudovitellium Detachment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Title: Treatment of Pseudovitellium Detachment', 'description': 'Open-Label Anecortave Acetate Sterile Suspension(15mg)', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension (15 mg)']}], 'interventions': [{'name': 'Anecortave Acetate Sterile Suspension (15 mg)', 'type': 'DRUG', 'armGroupLabels': ['Title: Treatment of Pseudovitellium Detachment']}]}, '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': 'Lawrence Yannuzzi, 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': 'Lawrence A. Yannuzzi, M.D.', 'investigatorFullName': 'Joan', 'investigatorAffiliation': 'Manhattan Eye, Ear & Throat Hospital'}}}}