A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Information source: Manhattan Eye, Ear & Throat Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Central Serous Chorioretinopathy
Intervention: Ketoconazole (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Manhattan Eye, Ear & Throat Hospital Official(s) and/or principal investigator(s):
K. Bailey Freund, MD, Principal Investigator, Affiliation: Manhattan Eye, Ear & Throat Hospital
Overall contact:
Leandro Maranan, Phone: 212-605-3777, Email: lmaranan@retinal-research.org
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).
Clinical Details
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
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.
A repeat and 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Leandro Maranan, Phone: 212-605-3777, Email: lmaranan@retinal-research.org
Manhattan Eye, Ear & Throat Hospital, New York, New York 10021, United States; Recruiting
Leandro Maranan, Phone: 212-605-3777, Email: lmaranan@retinal-research.org
Additional Information
Starting date: May 2005
Last updated: November 7, 2007
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