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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02354170
First Posted: February 3, 2015
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ophthalmic Consultants of Boston
Information provided by (Responsible Party):
Roger Goldberg, M.D., MBA, Bay Area Retina Associates
  Purpose
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.

Condition Intervention Phase
Central Serous Chorioretinopathy Drug: Mifepristone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (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)

Resource links provided by NLM:


Further study details as provided by Roger Goldberg, M.D., MBA, Bay Area Retina Associates:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: January 2015
Study Completion Date: April 27, 2017
Primary Completion Date: April 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Roger Goldberg, M.D., MBA
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
  More Information

Publications:

Responsible Party: Roger Goldberg, M.D., MBA, Ophthalmologist, Retina and Vitreous, Bay Area Retina Associates
ClinicalTrials.gov Identifier: NCT02354170     History of Changes
Other Study ID Numbers: STOMP-CSC
First Submitted: January 29, 2015
First Posted: February 3, 2015
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Roger Goldberg, M.D., MBA, Bay Area Retina Associates:
Central Serous Chorioretinopathy, CSC

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents