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雷珠单抗与康博西普治疗老年性黄斑性变性的前瞻性队列研究
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注册号:

Registration number:

ChiCTR-OPC-17013023 

最近更新日期:

Date of Last Refreshed on:

2017-11-14 

注册时间:

Date of Registration:

2017-10-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

雷珠单抗与康博西普治疗老年性黄斑性变性的前瞻性队列研究 

Public title:

Conbercept vs Ranibizumab for patients with age-related macular degeneration: a prospective cohort study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

雷珠单抗与康博西普治疗老年性黄斑性变性的有效性、安全性及成本效果评价 

Scientific title:

Evaluation of the effectiveness, safety and cost-effectiveness of Conbercept vs Ranibizumab for patients with age-related macular degeneration 

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:

张家兴 

研究负责人:

张家兴 

Applicant:

Jiaxing Zhang 

Study leader:

Jiaxing Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13984817008 

研究负责人电话:

Study leader's telephone:

+86 13984817008 

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:

zjx19870619@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zjx19870619@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

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:

贵州省贵阳市南明区中山东路83号 

研究负责人通讯地址:

贵州省贵阳市南明区中山东路83号 

Applicant address:

83 Zhongshandong Road, Nanming District, Guiyang, Guizhou, China 

Study leader's address:

83 Zhongshandong Road, Nanming District, Guiyang, Guizhou, China 

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:

贵州省人民医院 

Applicant's institution:

Guizhou Provincial People's Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017113 

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:

贵州省人民医院医学伦理委员会 

Name of the ethic committee:

medical ethics committee of Guizhou Provincial Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-25 

伦理委员会联系人:

田晓滨 

Contact Name of the ethic committee:

Tian Xiaobin 

伦理委员会联系地址:

贵州省贵阳市南明区中山东路83号 

Contact Address of the ethic committee:

83 Zhongshandong Road, Nanming District, Guiyang, Guizhou, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

贵州省人民医院 

Primary sponsor:

Guizhou Provincial People's Hospital 

研究实施负责(组长)单位地址:

贵州省贵阳市南明区中山东路83号 

Primary sponsor's address:

83 Zhongshandong Road, Nanming District, Guiyang, Guizhou, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou

City:

Guiyang

单位(医院):

贵州省人民医院

具体地址:

南明区中山东路83号

Institution
hospital:

Guizhou Provincial People's Hospital

Address:

83 Zhongshandong Road, Nanming District, Guiyang, Guizhou, China

经费或物资来源:

自筹 

Source(s) of funding:

Independently 

研究疾病:

老年黄斑性变性 

Target disease:

Age-related macular degeneration 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价雷珠单抗与康博西普治疗AMD的有效性。 评价雷珠单抗与康博西普治疗AMD的长期安全性。 评价雷珠单抗与康博西普治疗AMD的药物经济学特征。 

Objectives of Study:

To evaluate the effectiveness of Ranibizumab vs Conbercept for AMD; To evaluate the long term safety of Ranibizumab vs Conbercept for AMD; To evaluate the cost-effectiveness of Ranibizumab vs Conbercept for AMD. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

50岁以上; 根据《中国老年性黄斑变性临床诊断治疗路径》确诊为湿性AMD的患者; 愿意接受VEGF拮抗剂雷珠单抗或康博西普治疗; 签署知情同意书,愿意参加本研究的患者。 

Inclusion criteria

Patients aged more than 50 years old; Patients diagnosed with wet AMD; Patients willing to be treated with the anti-VEGF agents; Patients signed informed consent and were willing to participate in this study. 

排除标准:

无 

Exclusion criteria:

None 

研究实施时间:

Study execute time:

From2017-11-01To 2020-10-31 

干预措施:

Interventions:

组别:

康博西普组

样本量:

150

Group:

Conbercept-group

Sample size:

干预措施:

康博西普

干预措施代码:

Intervention:

Conbercept

Intervention code:

组别:

雷珠单抗组

样本量:

150

Group:

Ranibizumab-group

Sample size:

干预措施:

雷珠单抗

干预措施代码:

Intervention:

Ranibizumab

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

贵州省 

市(区县):

贵阳市 

Country:

China 

Province:

Guizhou 

City:

Guiyang 

单位(医院):

贵州省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guizhou Provincial People's Hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

最佳矫正视力

指标类型:

主要指标 

Outcome:

best-corrected visual acuity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中央视网膜厚度

指标类型:

次要指标 

Outcome:

central retinal thickness

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼内压

指标类型:

次要指标 

Outcome:

intraocular pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆VEGF含量

指标类型:

次要指标 

Outcome:

plasma level of VEGF

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

主要指标 

Outcome:

Quality of life

Type:

Primary indicator 

测量时间点:

测量方法:

中文版低视力者生存质量量表,CLVQL

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

主要指标 

Outcome:

Adverse Events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 50 years
最大 Max age 85 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):

非随机

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

Non-randomized

盲法:

无法对患者及实施干预(玻璃体注射)的医师实施盲法。 对测量结局的医师和药师实施盲法:测量结局的医师不是实施干预的医师,且不知道患者的分组情况。 对数据分析者实施盲法:以代号标示分组,数据分析者不知道患者的分组情况。

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

http://www.chictr.org.cn

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

http://www.chictr.org.cn

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:

数据库建立:根据CRF的条目,采用access软件建立研究数据库。 数据录入:双人独立录入,采用逻辑检查核对数据 数据核查:确定质控人员及其职责,临床及药剂科各1名,定期核查数据,检查研究进度。

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

The research data base was established by Access software, according the Case Record Form. Two investigators input data independently, and the data was checked by logical method. Quality control personnel checked the data and research progress at regular intervals.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-10-18
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