Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

- 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)

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
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.