Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

Description

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 Start Date

January 2015

Estimated Completion Date

December 2016

Interventions

  • Drug: Mifepristone
  • Drug: Placebo

Specialties

  • Ophthalmology: Neuro-Ophthalmology
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Central Serous Chorioretinopathy
  • Mifepristone

Study ID

Bay Area Retina Associates -- STOMP-CSC

Status

Unknown

Trial ID

NCT02354170

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

30

Sponsor

Bay Area Retina Associates

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 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles Jeffrey S Heier MD 800-635-0489 JSHEIER@eyeboston.com
Bay Area Retina Associates - Walnut Creek, California 2,673.8 miles Roger A Goldberg MD MBA 925-943-6800 rgoldberg@bayarearetina.com

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