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