NCT04300881终止2 期
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Wagner Macula & Retina Center1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年10月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Changes from baseline in Central Foveal Thickness (CFT) over time
研究概览
简要总结
Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years of age
- •Symptomatic VMA, VMT, or macular hole
- •BCVA 20/30 - CF 3' Snellen equivalent
- •Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
- •JETREA® treatment naïve
排除标准
- •Patients who are pregnant, planning to become pregnant, or breastfeeding a child
- •Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) > 0.8 despite treatment with anti-glaucoma medication)
- •Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
- •Inability to comply with study or follow-up procedures
- •Women who may become pregnant or lactating or intend to become pregnant during the study
- •Known drug allergy to ocriplasmin or eplerenone
- •Patients with known contraindications Eplerenone as outlined in the package insert
研究组 & 干预措施
Treatment
Experimental
Eplerenone
干预措施: Eplerenone (Drug)
结局指标
主要结局
Changes from baseline in Central Foveal Thickness (CFT) over time
时间窗: through study completion, an average of 1 year
Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity
次要结局
- Changes from baseline in Best Corrected Visual Acuity (BCVA) over time(through study completion, an average of 1 year)
研究者
研究点 (1)
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