Clinical Trial: Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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)

Brief 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 Summary:

• 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 enrol
  Sponsor: Roger Goldberg, M.D., MBA
  

  Current Primary Outcome: 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.
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • 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
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Bay Area Retina Associates
  

  Dates:
  Date Received: January 29, 2015
  Date Started: January 2015
  Date Completion: December 2016
  Last Updated: February 2, 2016
  Last Verified: February 2016