Back to resultsA Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole (CSC/Keto)
Primary Purpose
Chronic Central Serous Chorioretinopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ketoconazole
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Central Serous Chorioretinopathy
Eligibility Criteria
Inclusion Criteria: Age less than 60 years 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). Be able to return for all study visits for 3 months' duration. Be able to provide written informed consent Must have sufficiently clear media to allow for adequate fundus photography Exclusion Criteria: Have choroidal neovascularization. Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization. Have additional eye disease that compromises the visual acuity of the study eye. Are receiving any systemic steroid therapy Have any significant medical history Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study. Have any history of ocular conditions that may mimic CSC Are pregnant
Sites / Locations
- Manhattan Eye, Ear & Throat Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug: ketoconazole
Arm Description
Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks --------------------------------------------------------------------------------
Outcomes
Primary Outcome Measures
Visual acuity (ETDRS) after 6 weeks of treatment
Secondary Outcome Measures
Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
Full Information
NCT ID
NCT00211393
First Posted
September 13, 2005
Last Updated
October 24, 2012
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
LuEsther T. Mertz Retinal Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00211393
Brief Title
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Acronym
CSC/Keto
Official Title
A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
LuEsther T. Mertz Retinal Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
Repeat Liver and Adrenal function tests will be done at weeks 5-6 and 10 visits.
On 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug: ketoconazole
Arm Type
Experimental
Arm Description
Drug: ketoconazole
Other Names:
ketoconazole
600mg. /day for 6 weeks
--------------------------------------------------------------------------------
Intervention Type
Drug
Intervention Name(s)
ketoconazole
Intervention Description
600mg. /day for 6 weeks
Primary Outcome Measure Information:
Title
Visual acuity (ETDRS) after 6 weeks of treatment
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age less than 60 years
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).
Be able to return for all study visits for 3 months' duration.
Be able to provide written informed consent
Must have sufficiently clear media to allow for adequate fundus photography
Exclusion Criteria:
Have choroidal neovascularization.
Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
Have additional eye disease that compromises the visual acuity of the study eye.
Are receiving any systemic steroid therapy
Have any significant medical history
Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
Have any history of ocular conditions that may mimic CSC
Are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Bailey Freund, MD
Organizational Affiliation
Manhattan Eye, Ear & Throat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eye, Ear & Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
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