A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole (CSC/Keto)

• ClinicalTrials.gov Identifier: NCT00211393
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: October 25, 2012
• Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborator: LuEsther T. Mertz Retinal Research Center
• Information provided by (Responsible Party): Joan, Manhattan Eye, Ear & Throat Hospital

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Chronic Central Serous Chorioretinopathy	Drug: ketoconazole	Phase 2

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of The Treatment of Central Serous Chorioretinopathy With Ketoconazole.
• Study Start Date: May 2005
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Drug: ketoconazole; Drug: ketoconazole Other Names: ketoconazole 600mg. /day for 6 weeks --------------------------------------------------------------------------------	Drug: ketoconazole; 600mg. /day for 6 weeks

Outcome Measures

Primary Outcome Measures :

1. Visual acuity (ETDRS) after 6 weeks of treatment [ Time Frame: 18 weeks ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Manhattan Eye, Ear & Throat Hospital

New York, New York, United States, 10021

Sponsors and Collaborators

Manhattan Eye, Ear & Throat Hospital

LuEsther T. Mertz Retinal Research Center

Investigators

• Principal Investigator: K. Bailey Freund, MD; Manhattan Eye, Ear & Throat Hospital

More Information

• Responsible Party: Joan, K. Bailey Freund, M.D., Manhattan Eye, Ear & Throat Hospital
• ClinicalTrials.gov Identifier: NCT00211393
• Other Study ID Numbers: M00.013
• First Posted: September 21, 2005
• Last Update Posted: October 25, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Central Serous Chorioretinopathy; Retinal Diseases; Eye Diseases; Ketoconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors