NCT02354170

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Roger Goldberg, M.D., MBA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Central Serous Chorioretinopathy

Interventions

Type	Name	Description
DRUG	Mifepristone
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-04-27
• Completion: 2017-04-27
• First posted: 2015-02-03
• Last updated: 2017-07-26

Locations

2 sites across 1 country: United States