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

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Brief Title

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

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 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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Visual acuity (ETDRS) after 6 weeks of treatment

Secondary Outcome

 Changes in the choroidal vascular pattern as observed on FA and changes at the posterior pole as measured with optical coherence tomography

Condition

Chronic Central Serous Chorioretinopathy

Intervention

ketoconazole

Study Arms / Comparison Groups

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

May 2005

Completion Date

April 2008

Primary Completion Date

March 2008

Eligibility 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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

K. Bailey Freund, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00211393

Organization ID

M00.013


Responsible Party

Principal Investigator

Study Sponsor

Manhattan Eye, Ear & Throat Hospital

Collaborators

 LuEsther T. Mertz Retinal Research Center

Study Sponsor

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


Verification Date

October 2012