A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole (CSC/Keto)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00211393|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Central Serous Chorioretinopathy||Drug: ketoconazole||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.|
|Study Start Date :||May 2005|
|Primary Completion Date :||March 2008|
|Study Completion Date :||April 2008|
Experimental: Drug: ketoconazole
600mg. /day for 6 weeks
600mg. /day for 6 weeks
- Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211393
|United States, New York|
|Manhattan Eye, Ear & Throat Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||K. Bailey Freund, MD||Manhattan Eye, Ear & Throat Hospital|