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

NCT00211393 | Completed Phase 2

• 1 other identifier: M00.013
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• Visual acuity (ETDRS) after 6 weeks of treatment

  18 weeks

Secondary Outcomes (1)

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

  18 weeks

Study Arms (1)

Drug: ketoconazole

EXPERIMENTAL

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

Drug: ketoconazole

Interventions

ketoconazole DRUG

600mg. /day for 6 weeks

Drug: ketoconazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• LuEsther T. Mertz Retinal Research Center: collaborator

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• K. Bailey Freund, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: K. Bailey Freund, M.D.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (1)