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

Chronic Central Serous Chorioretinopathy Clinical Trial

— CSC/Keto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211393
• Other study ID #: M00.013
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: October 24, 2012
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2012
• Source: Manhattan Eye, Ear & Throat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

Intervention

Drug:
• ketoconazole
600mg. /day for 6 weeks

Locations

Country	Name	City	State
United States	Manhattan Eye, Ear & Throat Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Eye, Ear & Throat Hospital	LuEsther T. Mertz Retinal Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity (ETDRS) after 6 weeks of treatment		18 weeks	Yes
Secondary	Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography		18 weeks	Yes