Short-Term Oral Mifepristone for Central Serous Chorioretinopathy (STOMP-CSC)
|Central Serous Chorioretinopathy||Drug: Mifepristone Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|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)|
- Resolution of Sub-retinal Fluid [ Time Frame: 4 weeks after treatment ]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.
- Change in sub-retinal fluid and/or intraretinal fluid [ Time Frame: Week 1, 2, 4, and 8 ]Change compared to Baseline in subretinal fluid and/or intraretinal fluid on OCT at Week 1, 2, 4, and 8,
- Best Corrected Visual Acuity [ Time Frame: Week 1, 2, 4, and 8 ]Change compared to Baseline in ETDRS BCVA at Week 1, 2, 4, and 8.
- Change in macular thickness [ Time Frame: Week 1, 2, 4, and 8 ]Change compared to Baseline in central macular circle thickness on OCT, automatically calculated with OCT software at Week 1, 2, 4, and 8.
- Change in foveal thickness [ Time Frame: Week 1, 2, 4, and 8 ]Change compared to Baseline in thickness of subretinal fluid under the fovea on OCT, manually calculated at Week 1, 2, 4, and 8
- Change in choroidal thickness [ Time Frame: Week 1, 2, 4, and 8 ]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.
- Dye leakage in vasculature [ Time Frame: Week 4 and 8 ]Change compared to Baseline in dye leakage characteristics on fluorescein and indocyanine green angiography at Week 4 and Week 8.
- Change in OCT characteristics in the fellow eye [ Time Frame: Week 8 ]Change compared to Baseline in the same OCT characteristics listed above, in the fellow eye.
- Proportion of acute vs. chronic CSC patients [ Time Frame: Week 8 ]Proportion of acute versus chronic CSC patients as determined at Baseline, with the above outcomes analyzed for each sub-group.
- Safety and Tolerability Characteristics [ Time Frame: Week 8 ]Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02354170
|Contact: Roger A Goldberg, M.D., MBAfirstname.lastname@example.org|
|Contact: Jeffery S Heier, M.D.||800-635-0489||JSHEIER@eyeboston.com|
|United States, California|
|Bay Area Retina Associates||Recruiting|
|Walnut Creek, California, United States, 94598|
|Contact: Roger A Goldberg, M.D., MBA 925-943-6800 email@example.com|
|Principal Investigator: Roger A Goldberg, M.D., MBA|
|United States, Massachusetts|
|Ophthalmic Consultants of Boston||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jeffrey S Heier, M.D. 800-635-0489 JSHEIER@eyeboston.com|
|Principal Investigator: Jeffrey S Heier, M.D.|
|Principal Investigator:||Roger A Goldberg, M.D., MBA||Bay Area Retina Associates|
|Principal Investigator:||Jeffrey S Heier, M.D.||Ophthalmic Consultants of Boston|