Trial | NCT00211393  Report issue

Title

A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole
A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    5
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.
Study Started
May 31
2005
Primary Completion
Mar 31
2008
Study Completion
Apr 30
2008
Last Update
Oct 25
2012
Estimate

Drug ketoconazole

600mg. /day for 6 weeks

Drug: ketoconazole Experimental

Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks --------------------------------------------------------------------------------

Criteria 

Inclusion Criteria:

Age less than 60 years
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).
Be able to return for all study visits for 3 months' duration.
Be able to provide written informed consent
Must have sufficiently clear media to allow for adequate fundus photography

Exclusion Criteria:

Have choroidal neovascularization.
Have any evidence of clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, or other precursor of choroidal neovascularization.
Have additional eye disease that compromises the visual acuity of the study eye.
Are receiving any systemic steroid therapy
Have any significant medical history
Have a history of severe hypersensitivity reaction to any of the dyes or the drug used in the study.
Have any history of ocular conditions that may mimic CSC
Are pregnant
No Results Posted