Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-30 @ 4:15 PM
Study NCT ID:
NCT01015495
Status:
WITHDRAWN
Last Update Posted:
2012-07-02
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000793', 'term': 'Angioid Streaks'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not enough patients within the time frame to allow for a meaningful study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-28', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)', 'timeFrame': 'Month 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12', 'timeFrame': 'Month 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['angioid streaks', 'CNV', 'intra vitreal ranibizumab'], 'conditions': ['Angioid Streaks']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uic.edu/com/eye/', 'label': 'UIC-Ophthalmology home page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.', 'detailedDescription': 'Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study\n* Age \\> 18 years\n* Angioid streaks\n* Subfoveal CNV of recent onset with the following characteristics\n* Absence of subfoveal fibrosis\n* Fibrosis less than 25% of the lesion\n* Presence of blood, subretinal fluid, and/or lipid\n* New onset symptoms within 12 weeks\n* Visual acuity 20/40 to 20/800 on an ETDRS chart\n\nExclusion Criteria:\n\n* Prior treatment of subfoveal CNV in the study eye\n* Age-related macular degeneration\n* Uncontrolled glaucoma\n* High myopia (\\> -10.00 D spherical equivalent)\n* Prior retinal detachment\n* Media opacity preventing adequate view of the retina\n* Planned cataract surgery in the next 3 months\n* Current chemotherapy for cancer\n* Immunocompromised state\n* Pregnancy (positive pregnancy test) or lactation\n* Premenopausal women not using adequate contraception.\n* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated\n* Participation in another simultaneous medical investigation or trial\n* History of any previous treatment for angioid streaks'}, 'identificationModule': {'nctId': 'NCT01015495', 'briefTitle': 'Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks', 'orgStudyIdInfo': {'id': 'fvf 3763s'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ranibizumab', 'interventionNames': ['Drug: ranibizumab']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': '0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage', 'armGroupLabels': ['ranibizumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jennifer I Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UIC Eye and Ear Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology, Director of Retina Services, Department of Ophthalmology and Visual Sciences', 'investigatorFullName': 'Jennifer I. Lim', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}