CompletedPhase 2

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

United States16 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Age less than 18
✕. Persons with impaired decision-making ability.
✕. Women who are known to be breast-feeding, pregnant or are actively trying to conceive.
✕. Additional eye disease affecting the macula, posterior retina, or ocular media that would limit or prevent the acquisition of OCT and angiographic images.
✕. 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.
✕. Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
✕. Active intraocular inflammation (grade trace or above) in the study eye.
✕. Patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus.

What they're measuring

Resolution of Sub-retinal Fluid

Timeframe: 4 weeks after treatment

Trial details

NCT IDNCT02354170

SponsorRoger Goldberg, M.D., MBA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-27

View on ClinicalTrials.gov More Central Serous Chorioretinopathy trials