Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

• Status: Completed
• Trial end date: 2017-04-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roger Goldberg, M.D., MBA
• Collaborator: Ophthalmic Consultants of Boston
• Treatments: Mifepristone

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 or6. 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.