NCT02354170已完成2 期
Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC)
Roger Goldberg, M.D., MBA2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Resolution of Sub-retinal Fluid
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cohort 1 (m300)
Experimental
One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks
干预措施: Mifepristone (Drug)
Cohort 2 (m900)
Experimental
Three (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks
干预措施: Mifepristone (Drug)
Cohort 3 (Placebo)
Placebo Comparator
Placebo taken once daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Resolution of Sub-retinal Fluid
时间窗: 4 weeks after treatment
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.
次要结局
- Dye leakage in vasculature(Week 4 and 8)
- Change in foveal thickness(Week 1, 2, 4, and 8)
- Change in OCT characteristics in the fellow eye(Week 8)
- Change in sub-retinal fluid and/or intraretinal fluid(Week 1, 2, 4, and 8)
- Change in choroidal thickness(Week 1, 2, 4, and 8)
- Safety and Tolerability Characteristics(Week 8)
- Best Corrected Visual Acuity(Week 1, 2, 4, and 8)
- Change in macular thickness(Week 1, 2, 4, and 8)
- Proportion of acute vs. chronic CSC patients(Week 8)
研究者
Roger Goldberg, M.D., MBA
Ophthalmologist, Retina and Vitreous
Bay Area Retina Associates
研究点 (2)
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