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Short-Term Oral Mifepristone for Central Serous Chorioretinopathy (STOMP-CSC)

Primary Purpose

Central Serous Chorioretinopathy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Mifepristone

Placebo

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central Serous Chorioretinopathy, CSC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
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.

Sites / Locations

Bay Area Retina Associates
Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Cohort 1 (m300)

Cohort 2 (m900)

Cohort 3 (Placebo)

Arm Description

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

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

Placebo taken once daily for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in sub-retinal fluid and/or intraretinal fluid

Change compared to Baseline in subretinal fluid and/or intraretinal fluid on OCT at Week 1, 2, 4, and 8,

Best Corrected Visual Acuity

Change compared to Baseline in ETDRS BCVA at Week 1, 2, 4, and 8.

Change in macular thickness

Change compared to Baseline in central macular circle thickness on OCT, automatically calculated with OCT software at Week 1, 2, 4, and 8.

Change in foveal thickness

Change compared to Baseline in thickness of subretinal fluid under the fovea on OCT, manually calculated at Week 1, 2, 4, and 8

Change in choroidal thickness

Change compared to Baseline in thickness of choroid under the fovea on enhanced-depth imaging OCT, manually calculated, at Week 1, 2, 4, and 8.

Dye leakage in vasculature

Change compared to Baseline in dye leakage characteristics on fluorescein and indocyanine green angiography at Week 4 and Week 8.

Change in OCT characteristics in the fellow eye

Change compared to Baseline in the same OCT characteristics listed above, in the fellow eye.

Proportion of acute vs. chronic CSC patients

Proportion of acute versus chronic CSC patients as determined at Baseline, with the above outcomes analyzed for each sub-group.

Safety and Tolerability Characteristics

Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events

Full Information

NCT ID

NCT02354170

First Posted

January 29, 2015

Last Updated

July 24, 2017

Sponsor

Roger Goldberg, M.D., MBA

Collaborators

Ophthalmic Consultants of Boston

1. Study Identification

Unique Protocol Identification Number

NCT02354170

Brief Title

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

Acronym

STOMP-CSC

Official Title

Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

April 27, 2017 (Actual)

Study Completion Date

April 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Roger Goldberg, M.D., MBA

Collaborators

Ophthalmic Consultants of Boston

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Chorioretinopathy

Keywords

Central Serous Chorioretinopathy, CSC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (m300)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2 (m900)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3 (Placebo)

Arm Type

Placebo Comparator

Arm Description

Placebo taken once daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Mifepristone

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Resolution of Sub-retinal Fluid

Description

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.

Time Frame

4 weeks after treatment

Secondary Outcome Measure Information:

Title

Change in sub-retinal fluid and/or intraretinal fluid

Description

Change compared to Baseline in subretinal fluid and/or intraretinal fluid on OCT at Week 1, 2, 4, and 8,

Time Frame

Week 1, 2, 4, and 8

Title

Best Corrected Visual Acuity

Description

Change compared to Baseline in ETDRS BCVA at Week 1, 2, 4, and 8.

Time Frame

Week 1, 2, 4, and 8

Title

Change in macular thickness

Description

Change compared to Baseline in central macular circle thickness on OCT, automatically calculated with OCT software at Week 1, 2, 4, and 8.

Time Frame

Week 1, 2, 4, and 8

Title

Change in foveal thickness

Description

Change compared to Baseline in thickness of subretinal fluid under the fovea on OCT, manually calculated at Week 1, 2, 4, and 8

Time Frame

Week 1, 2, 4, and 8

Title

Change in choroidal thickness

Description

Change compared to Baseline in thickness of choroid under the fovea on enhanced-depth imaging OCT, manually calculated, at Week 1, 2, 4, and 8.

Time Frame

Week 1, 2, 4, and 8

Title

Dye leakage in vasculature

Description

Change compared to Baseline in dye leakage characteristics on fluorescein and indocyanine green angiography at Week 4 and Week 8.

Time Frame

Week 4 and 8

Title

Change in OCT characteristics in the fellow eye

Description

Change compared to Baseline in the same OCT characteristics listed above, in the fellow eye.

Time Frame

Week 8

Title

Proportion of acute vs. chronic CSC patients

Description

Proportion of acute versus chronic CSC patients as determined at Baseline, with the above outcomes analyzed for each sub-group.

Time Frame

Week 8

Title

Safety and Tolerability Characteristics

Description

Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger A Goldberg, M.D., MBA

Organizational Affiliation

Bay Area Retina Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey S Heier, M.D.

Organizational Affiliation

Ophthalmic Consultants of Boston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bay Area Retina Associates

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

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Short-Term Oral Mifepristone for Central Serous Chorioretinopathy

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