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

NCT ID: NCT00211393

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Chronic Central Serous Chorioretinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug: ketoconazole

Drug: ketoconazole

Other Names:

ketoconazole

600mg. /day for 6 weeks

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Group Type EXPERIMENTAL

ketoconazole

Intervention Type DRUG

600mg. /day for 6 weeks

Interventions

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ketoconazole

600mg. /day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LuEsther T. Mertz Retinal Research Center

OTHER

Sponsor Role collaborator

Manhattan Eye, Ear & Throat Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joan

K. Bailey Freund, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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K. Bailey Freund, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Eye, Ear & Throat Hospital

Locations

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Manhattan Eye, Ear & Throat Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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M00.013

Identifier Type: -

Identifier Source: org_study_id