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| Name | Class |
|---|---|
| LuEsther T. Mertz Retinal Research Center | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: ketoconazole | Experimental | Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks -------------------------------------------------------------------------------- |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoconazole | Drug | 600mg. /day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (ETDRS) after 6 weeks of treatment | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography | 18 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K. Bailey Freund, MD | Manhattan Eye, Ear & Throat Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Eye, Ear & Throat Hospital | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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