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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Bay Area Retina Associates
Walnut Creek, California, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Resolution of Sub-retinal Fluid
Presence or absence of subretinal fluid on spectral-domain OCT after 4 weeks of treatment with mifepristone 300 or 900 mg daily, compared with placebo.
Time frame: 4 weeks after treatment
Change in sub-retinal fluid and/or intraretinal fluid
Change compared to Baseline in subretinal fluid and/or intraretinal fluid on OCT at Week 1, 2, 4, and 8,
Time frame: Week 1, 2, 4, and 8
Best Corrected Visual Acuity
Change compared to Baseline in ETDRS BCVA at Week 1, 2, 4, and 8.
Time frame: Week 1, 2, 4, and 8
Change in macular thickness
Change compared to Baseline in central macular circle thickness on OCT, automatically calculated with OCT software at Week 1, 2, 4, and 8.
Time frame: Week 1, 2, 4, and 8
Change in foveal thickness
Change compared to Baseline in thickness of subretinal fluid under the fovea on OCT, manually calculated at Week 1, 2, 4, and 8
Time frame: Week 1, 2, 4, and 8
Change in choroidal thickness
Change compared to Baseline in thickness of choroid under the fovea on enhanced-depth imaging OCT, manually calculated, at Week 1, 2, 4, and 8.
Time frame: Week 1, 2, 4, and 8
Dye leakage in vasculature
Change compared to Baseline in dye leakage characteristics on fluorescein and indocyanine green angiography at Week 4 and Week 8.
Time frame: Week 4 and 8
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Change in OCT characteristics in the fellow eye
Change compared to Baseline in the same OCT characteristics listed above, in the fellow eye.
Time frame: Week 8
Proportion of acute vs. chronic CSC patients
Proportion of acute versus chronic CSC patients as determined at Baseline, with the above outcomes analyzed for each sub-group.
Time frame: Week 8
Safety and Tolerability Characteristics
Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events
Time frame: Week 8