Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

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Brief Title

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

Official Title

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC)

Brief Summary

      The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg
      once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.
    

Detailed Description

      -  Prospective, randomized, double-masked, placebo-controlled dose-ranging study

        -  Eligible patients will be those with CSC, with symptoms of blurred or distorted vision,
           with the presence of sub-retinal fluid as documented on optical coherence tomography
           (OCT) in the central foveal sub-field

        -  Only one eye of a participant will be included in the study, although both eyes will be
           evaluated. In patients with bilateral CSC, the eye with more sub-foveal fluid on OCT
           will be the study eye.

        -  Patients will be evaluated and treated at one of two study centers:

      Ophthalmic Consultants of Boston (OCB), 50 Staniford St., Suite 600, Boston, MA

      Bay Area Retina Associates (BARA), 122 La Casa Via, Suite 223, Walnut Creek, CA

        -  All participants will receive a standard ophthalmic examination as well as fluorescein
           and indocyanine green angiography and macular OCT per protocol.

        -  30 patients will be enrolled, as follows:

           10 patients will be randomly assigned to Cohort 1, and will take one (1) mifepristone
           300-mg tablet (300 mg total dose) once daily by mouth for 4 weeks.

           10 patients will be randomly assigned to Cohort 2, and will take three (3) mifepristone
           300-mg tablet (900 mg total dose) once daily by mouth for 4 weeks.

           10 patients will be randomly assigned to Cohort 3, and will take placebo tablet(s) once
           daily by mouth for 4 weeks.

        -  After completing the enrollment criteria, a subject will be randomized 1:1:1 to Cohort
           1, 2, or 3.

        -  During the Baseline visit and at the Week 2, 4, and 8 visits, all subjects will have
           laboratory testing of the following lab tests: serum electrolytes, BUN and creatinine,
           liver function tests

        -  Prior to initiating dosing of the study drug, all women of child-bearing potential
           (WOCBP) will have a serum beta-HCG assessed to rule out pregnancy; all WOCBP who are
           enrolled in the study will be required to use barrier contraception throughout the
           study.

        -  Adverse events will be tracked at each visit (see "Data Safety and Monitoring Plan"
           below)
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Resolution of Sub-retinal Fluid

Secondary Outcome

 Change in sub-retinal fluid and/or intraretinal fluid

Condition

Central Serous Chorioretinopathy

Intervention

Mifepristone

Study Arms / Comparison Groups

 Cohort 1 (m300)
Description:  One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks

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

16

Start Date

January 2015

Completion Date

April 27, 2017

Primary Completion Date

April 27, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of central serous chorioretinopathy (CSC) with symptoms 6 weeks or prior
             documented episodes of sub-retinal fluid; patients who have had previous treatment for
             CSC may be included

          2. Presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in
             the central foveal sub-field

          3. Age 18 or over

          4. Willing and able to comply with clinic visits and study-related procedures

          5. Ability to give written informed consent

        Exclusion Criteria:

          1. Age less than 18

          2. Persons with impaired decision-making ability.

          3. Women who are known to be breast-feeding, pregnant or are actively trying to conceive.

          4. Additional eye disease affecting the macula, posterior retina, or ocular media that
             would limit or prevent the acquisition of OCT and angiographic images.

          5. At screening, serum potassium < LLN, BUN > 1.5 ULN, serum creatinine >1.5 ULN, AST >
             1.5 ULN, ALT >1.5 ULN, bilirubin > 1.5 ULN, alkaline phosphatase > 1.5 ULN, serum
             albumin >1.5 ULN or 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Roger A Goldberg, M.D., MBA, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02354170

Organization ID

STOMP-CSC


Responsible Party

Sponsor-Investigator

Study Sponsor

Roger Goldberg, M.D., MBA

Collaborators

 Ophthalmic Consultants of Boston

Study Sponsor

Roger A Goldberg, M.D., MBA, Principal Investigator, Bay Area Retina Associates


Verification Date

July 2017