Short-Term Oral Mifepristone for Central Serous Chorioretinopathy (STOMP-CSC)
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|ClinicalTrials.gov Identifier: NCT02354170|
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Central Serous Chorioretinopathy||Drug: Mifepristone Drug: Placebo||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 27, 2017|
|Actual Study Completion Date :||April 27, 2017|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354170
|United States, California|
|Bay Area Retina Associates|
|Walnut Creek, California, United States, 94598|
|United States, Massachusetts|
|Ophthalmic Consultants of Boston|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Roger A Goldberg, M.D., MBA||Bay Area Retina Associates|
|Principal Investigator:||Jeffrey S Heier, M.D.||Ophthalmic Consultants of Boston|