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
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
• Presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
• Age 18 or over
• Willing and able to comply with clinic visits and study-related procedures
• Ability to give written informed consent
Locations
United States
California
Bay Area Retina Associates
Walnut Creek
Massachusetts
Ophthalmic Consultants of Boston
Boston
Time Frame
Start Date: 2015-01
Completion Date: 2017-04-27
Participants
Target number of participants: 16
Treatments
Experimental: Cohort 1 (m300)
One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks
Experimental: Cohort 2 (m900)
Three (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks
Placebo_comparator: Cohort 3 (Placebo)
Placebo taken once daily for 4 weeks
Authors
Related Therapeutic Areas
Sponsors
Leads: Roger Goldberg, M.D., MBA
Collaborators: Ophthalmic Consultants of Boston