Clinical Trial: A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Summary:
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.
Sponsor: Manhattan Eye, Ear & Throat Hospital
Current Primary Outcome: Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]
Original Primary Outcome:
Current Secondary Outcome: 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 ]
Original Secondary Outcome:
Information By: Manhattan Eye, Ear & Throat Hospital
Dates:
Date Received: September 13, 2005
Date Started: May 2005
Date Completion:
Last Updated: October 24, 2012
Last Verified: October 2012
