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【ChiCTR1900021998】神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗

基本信息
登记号

ChiCTR1900021998

试验状态

正在进行

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2019-03-19

临床申请受理号

/

靶点

/

适应症

青光眼

试验通俗题目

神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗

试验专业题目

神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

The study will randomize 125 patients with primary open-angle glaucoma (POAG) to receive an oral supplement of nicotinamide riboside 300 mg/day or a placebo (corn starch capsules) with an objective of comparing the rates of RNFL thinning (primary outcome measure) measured with a swept-source OCT over 24 months of follow-up between the treatment arms.

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

Patients will be randomized with minimization using a free open source computer program MinimPy to receive nicotinamide riboside 300 mg/day or a placebo (corn starch) at the baseline visit. Both the investigators and the patients will be blinded for the treatment assignment.

盲法

Both the investigators and the patients will be blinded for the treatment assignment.

试验项目经费来源

Health and Medical Research Fund 2017

试验范围

/

目标入组人数

62;63

实际入组人数

/

第一例入组时间

2019-04-01

试验终止时间

2023-03-31

是否属于一致性

/

入选标准

Age >=18 years; best corrected VA >=20/40; IOP <= 28mmHg; no history of laser procedure or intraocular surgery other than uncomplicated cataract extraction; patients with evidence of progressive RNFL/GCIPL thinning detected by Guided Progression Analysis(GPA) or Trend-based Progression Analysis (TPA)；

排除标准

Pathological myopia; diseases that may cause visual field loss or optic disc abnormalities other than glaucoma; inability to perform reliable visual field; suboptimal quality of OCT images; and diabetic retinopathy/maculopathy; and a history of abnormal liver function.；

研究者信息
研究负责人姓名
试验机构

Research Fund Secretariat, Food and Health Bureau, The Government of HKSAR

研究负责人电话
研究负责人邮箱
研究负责人邮编

/

联系人通讯地址

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