ChiCTR1900021998 版本V1.2 版本创建时间2020/01/02 16:55:31 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR1900021998 

最近更新日期：

Date of Last Refreshed on：

2019-12-22 17:14:19 

注册时间：

Date of Registration：

2019-03-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗

Public title：

Nicotinamide riboside as a neuroprotective therapy for glaucoma – A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

神經保護劑煙醯胺核苷治療青光眼的隨機對照試驗

Scientific title：

Nicotinamide riboside as a neuroprotective therapy for glaucoma – A randomized controlled trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Leung Kai Shun Christopher 

研究负责人：

Leung Kai Shun Christopher 

Applicant：

Leung Kai Shun Christopher 

Study leader：

Leung Kai Shun Christopher 

申请注册联系人电话：

Applicant telephone：

+852 39435803

研究负责人电话：

Study leader's telephone：

+852 39435803

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

cksleung@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

cksleung@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www.ovs.cuhk.edu.hk/

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中國香港特別行政區新界旺角亞皆老街香港眼科醫院

研究负责人通讯地址：

中國香港特別行政區新界旺角亞皆老街香港眼科醫院

Applicant address：

3/F Hong Kong Eye Hospital, 147K Argyle Street, Mongkok, Hong Kong

Study leader's address：

3/F Hong Kong Eye Hospital, 147K Argyle Street, Mongkok, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學眼科與視覺科學系

Applicant's institution：

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學眼科與視覺科學系

Affiliation of the Leader：

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KC/KE-18-0098/FR-1

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

九龍中區/九龍東研究倫理委員會

Name of the ethic committee：

Research Ethics Committee (Kowloon Central / Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

2019-10-08 00:00:00

伦理委员会联系人：

Lyon Chan

Contact Name of the ethic committee：

Lyon Chan

伦理委员会联系地址：

中國香港特別行政區新界加士居道30號伊莉莎白女王醫院護理總部

Contact Address of the ethic committee：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 35067069

伦理委员会联系人邮箱：

Contact email of the ethic committee：

chanwf2@ha.org.hk

研究实施负责（组长）单位：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Primary sponsor's address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

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

具体地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Institution
hospital：

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

Address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

经费或物资来源：

Health and Medical Research Fund 2017

Source(s) of funding：

Health and Medical Research Fund 2017

Target disease：

Glaucoma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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 (sugar pill) 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  

Objectives of Study：

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 (sugar pill) 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

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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)

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2019-04-01 00:00:00至 To 2023-03-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2019-04-01 00:00:00 至 To 2023-03-30 00:00:00  

干预措施：

Interventions：

组别：

Group 1

样本量：

63

Group：

Group 1

Sample size：

干预措施：

Nicotinamide riboside 300mg/day

干预措施代码：

Intervention：

Nicotinamide riboside 300mg/day

Intervention code：

组别：

Group 2

样本量：

62

Group：

Group 2

Sample size：

干预措施：

Placebo

干预措施代码：

Intervention：

Placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

香港眼科醫院 

单位级别：

香港眼科醫院 

Institution
hospital：

Hong Kong Eye Hospital

Level of the institution：

Hong Kong Eye Hospital

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

威爾斯親王醫院 

单位级别：

威爾斯親王醫院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

香港中文大學眼科中心 

单位级别：

香港中文大學眼科中心 

Institution
hospital：

CUHK Eye Centre

Level of the institution：

CUHK Eye Centre

测量指标：

Outcomes：

指标中文名：

Comparing the rates of RNFL thinning measured with a swept-source OCT over 24 months of follow-up between the treatment arms

指标类型：

主要指标

Outcome：

Comparing the rates of RNFL thinning measured with a swept-source OCT over 24 months of follow-up between the treatment arms

Type：

Primary indicator

测量时间点：

24 months

测量方法：

Measure time point of outcome：

24 months

Measure method：

指标中文名：

Time to visual field progression

指标类型：

次要指标

Outcome：

Time to visual field progression

Type：

Secondary indicator

测量时间点：

Over 24 months

测量方法：

EMGT visual field progression criteria

Measure time point of outcome：

Over 24 months

Measure method：

EMGT visual field progression criteria

指标中文名：

Time to progressive RNFL/GCIPL thinning

指标类型：

次要指标

Outcome：

Time to progressive RNFL/GCIPL thinning

Type：

Secondary indicator

测量时间点：

Over 24 months

测量方法：

TPA

Measure time point of outcome：

Over 24 months

Measure method：

TPA

指标中文名：

The rates of change of visual field mean deviation and visual sensitivity at individual visual field locations

指标类型：

次要指标

Outcome：

The rates of change of visual field mean deviation and visual sensitivity at individual visual field locations

Type：

Secondary indicator

测量时间点：

Over 24 months

测量方法：

Measure time point of outcome：

Over 24 months

Measure method：

指标中文名：

Changes in visual field mean deviation (MD) and visual sensitivity at individual locations

指标类型：

次要指标

Outcome：

Changes in visual field mean deviation (MD) and visual sensitivity at individual locations

Type：

Secondary indicator

测量时间点：

1 month

测量方法：

Measure time point of outcome：

1 month

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Patients will be randomized using computer generated random numbers to receive nicotinamide riboside 300mg/day or a placebo (sugar) at the baseline visit. Both the investigators and the patients will be blinded for the treatment assignment.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Patients will be randomized using computer generated random numbers to receive nicotinamide riboside 300mg/day or a placebo (sugar) at the baseline visit. Both the investigators and the patients will be blinded for the treatment assignment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

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

Blinding：

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

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

IPD will not be shared

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

IPD will not be shared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-03-19 22:51:47