Short-Term Oral Mifepristone for Central Serous Chorioretinopathy (STOMP-CSC)

July 24, 2017 updated by: Roger Goldberg, M.D., MBA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
  3. Age 18 or over
  4. Willing and able to comply with clinic visits and study-related procedures
  5. Ability to give written informed consent

Exclusion Criteria:

  1. Age less than 18
  2. Persons with impaired decision-making ability.
  3. Women who are known to be breast-feeding, pregnant or are actively trying to conceive.
  4. Additional eye disease affecting the macula, posterior retina, or ocular media that would limit or prevent the acquisition of OCT and angiographic images.
  5. At screening, serum potassium < LLN, BUN > 1.5 ULN, serum creatinine >1.5 ULN, AST > 1.5 ULN, ALT >1.5 ULN, bilirubin > 1.5 ULN, alkaline phosphatase > 1.5 ULN, serum albumin >1.5 ULN or <LLN.
  6. Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
  7. Active intraocular inflammation (grade trace or above) in the study eye.
  8. Patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus.
  9. Patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation).
  10. Women with a history of unexplained vaginal bleeding and women with endometrial hyperplasia with atypia or endometrial carcinoma.
  11. Patients with prior hypersensitivity reactions to mifepristone or to any of the product components.

  12. Patients with known hypersensitivity to fluorescein or indocyanine green dyes.

    • WOCBP must be willing to practice adequate contraception during the study (adequate contraceptive measures include intrauterine device [IUD]; bilateral tubal ligation; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly). Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (m300)
One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks
Drug: Mifepristone
Experimental: Cohort 2 (m900)
Three (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks
Drug: Mifepristone
Placebo Comparator: Cohort 3 (Placebo)
Placebo taken once daily for 4 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
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.
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.
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
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.
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.
Week 4 and 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.
Week 8
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.
Week 8
Safety and Tolerability Characteristics
Time Frame: Week 8
Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roger Goldberg, M.D., MBA

Collaborators

Ophthalmic Consultants of Boston

Investigators

  • Principal Investigator: Roger A Goldberg, M.D., MBA, Bay Area Retina Associates
  • Principal Investigator: Jeffrey S Heier, M.D., Ophthalmic Consultants of Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOMP-CSC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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