Brief Title
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Official Title
A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Visual acuity (ETDRS) after 6 weeks of treatment
Secondary Outcome
Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography
Condition
Chronic Central Serous Chorioretinopathy
Intervention
ketoconazole
Study Arms / Comparison Groups
Drug: ketoconazole
Description: Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks --------------------------------------------------------------------------------
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
May 2005
Completion Date
April 2008
Primary Completion Date
March 2008
Eligibility Criteria
Inclusion Criteria:
1. Age less than 60 years
2. 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).
3. Be able to return for all study visits for 3 months' duration.
4. Be able to provide written informed consent
5. Must have sufficiently clear media to allow for adequate fundus photography
Exclusion Criteria:
1. Have choroidal neovascularization.
2. Have any evidence of clinically significant intraocular inflammation, angioid streaks,
presumed ocular histoplasmosis syndrome, or other precursor of choroidal
neovascularization.
3. Have additional eye disease that compromises the visual acuity of the study eye.
4. Are receiving any systemic steroid therapy
5. Have any significant medical history
6. Have a history of severe hypersensitivity reaction to any of the dyes or the drug used
in the study.
7. Have any history of ocular conditions that may mimic CSC
8. Are pregnant
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
K. Bailey Freund, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00211393
Organization ID
M00.013
Responsible Party
Principal Investigator
Study Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
LuEsther T. Mertz Retinal Research Center
Study Sponsor
K. Bailey Freund, MD, Principal Investigator, Manhattan Eye, Ear & Throat Hospital
Verification Date
October 2012