Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT00211393
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2008-04', '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': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity (ETDRS) after 6 weeks of treatment', 'timeFrame': '18 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography', 'timeFrame': '18 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Central Serous Chorioretinopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of an adrenocorticoid antagonist (ketoconazole), 600 mg per day for 4 weeks, in the treatment of patients with central serous chorioretinopathy (CSC).', 'detailedDescription': 'A complete ophthalmic evaluation and tests: autofluorescence and Fluorescein angiography, Color Fundus Photography, OCT, including liver and adrenal functions and pregnancy test, if applicable will be done on the screening visit. If the patient is eligible, the patient will be started on ketoconazole 600 mg per day by mouth for the following next 6 weeks. The patient will be rechecked at weeks 5-6, 10,14 and 18. During all these visits a complete ophthalmic examination autofluorescence, OCT, and color fundus photographs will be done.\n\nRepeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.\n\nOn the exit visit, all the ophthalmic tests and procedures on the baseline visit will be done. Adverse events, and concomitant medications and treatments will be reported on all visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age less than 60 years\n2. Must have clinical signs of CSC with leakage from the level of the RPE during fluorescein angiography and neurosensory detachment documented by optical coherence tomography (OCT).\n3. Be able to return for all study visits for 3 months' duration.\n4. Be able to provide written informed consent\n5. Must have sufficiently clear media to allow for adequate fundus photography\n\nExclusion Criteria:\n\n1. Have choroidal neovascularization.\n2. Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.\n3. Have additional eye disease that compromises the visual acuity of the study eye.\n4. Are receiving any systemic steroid therapy\n5. Have any significant medical history\n6. Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.\n7. Have any history of ocular conditions that may mimic CSC\n8. Are pregnant"}, 'identificationModule': {'nctId': 'NCT00211393', 'acronym': 'CSC/Keto', 'briefTitle': 'A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole', 'organization': {'class': 'OTHER', 'fullName': 'Manhattan Eye, Ear & Throat Hospital'}, 'officialTitle': 'A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.', 'orgStudyIdInfo': {'id': 'M00.013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: ketoconazole', 'description': 'Drug: ketoconazole\n\nOther Names:\n\nketoconazole\n\n600mg. /day for 6 weeks\n\n\\--------------------------------------------------------------------------------', 'interventionNames': ['Drug: ketoconazole']}], 'interventions': [{'name': 'ketoconazole', 'type': 'DRUG', 'description': '600mg. /day for 6 weeks', 'armGroupLabels': ['Drug: ketoconazole']}]}, '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': 'K. Bailey Freund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manhattan Eye, Ear & Throat Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manhattan Eye, Ear & Throat Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'LuEsther T. Mertz Retinal Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'K. Bailey Freund, M.D.', 'investigatorFullName': 'Joan', 'investigatorAffiliation': 'Manhattan Eye, Ear & Throat Hospital'}}}}