Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

NCT02354170 | Completed Phase 2 DMC

• 1 other identifier: STOMP-CSC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Central Serous Chorioretinopathy

Keywords

Central Serous Chorioretinopathy, CSC

Outcome Measures

Primary Outcomes (1)

• Resolution of Sub-retinal Fluid

  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.

  4 weeks after treatment

Secondary Outcomes (9)

• Change in sub-retinal fluid and/or intraretinal fluid

  Week 1, 2, 4, and 8

• Best Corrected Visual Acuity

  Week 1, 2, 4, and 8

• Change in macular thickness

  Week 1, 2, 4, and 8

• Change in foveal thickness

  Week 1, 2, 4, and 8

• Change in choroidal thickness

  Week 1, 2, 4, and 8

Study Arms (3)

Cohort 1 (m300)

EXPERIMENTAL

One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks

Drug: Mifepristone

Cohort 2 (m900)

EXPERIMENTAL

Three (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks

Drug: Mifepristone

Cohort 3 (Placebo)

PLACEBO COMPARATOR

Placebo taken once daily for 4 weeks

Drug: Placebo

Interventions

Mifepristone DRUG

Cohort 1 (m300); Cohort 2 (m900)

Placebo DRUG

Cohort 3 (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation).
• Women with a history of unexplained vaginal bleeding and women with endometrial hyperplasia with atypia or endometrial carcinoma.
• Patients with prior hypersensitivity reactions to mifepristone or to any of the product components.
• 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.

Sponsors & Collaborators

• Roger Goldberg, M.D., MBA: lead
• Ophthalmic Consultants of Boston: collaborator

Study Sites (2)

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Roger A Goldberg, M.D., MBA

  Bay Area Retina Associates

  PRINCIPAL INVESTIGATOR

• Jeffrey S Heier, M.D.

  Ophthalmic Consultants of Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist, Retina and Vitreous

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

US (2)