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明睛颗粒治疗湿性年龄相关性黄斑变性前瞻性、随机、双盲、安慰剂平行对照、多中心研究
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注册号:

Registration number:

ChiCTR2000035990 

最近更新日期:

Date of Last Refreshed on:

2020-09-07 

注册时间:

Date of Registration:

2020-08-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

明睛颗粒治疗湿性年龄相关性黄斑变性前瞻性、随机、双盲、安慰剂平行对照、多中心研究 

Public title:

Mingjing Granule in the treatment of neovascular age-related macular degeneration: a prospective, randomized, double-blind, placebo parallel controlled, multicenter clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

明睛颗粒治疗湿性年龄相关性黄斑变性前瞻性、随机、双盲、安慰剂平行对照、多中心研究 

Scientific title:

Mingjing Granule in the treatment of neovascular age-related macular degeneration: a prospective, randomized, double-blind, placebo parallel controlled, multicenter clinical 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:

ChiMCTR2000003625 

申请注册联系人:

李亚敏 

研究负责人:

梁丽娜 

Applicant:

Yamin Li 

Study leader:

Lina Liang 

申请注册联系人电话:

Applicant telephone:

+86 15039082070 

研究负责人电话:

Study leader's telephone:

+86 010-68683451 

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:

1542664515@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

lianglina163@163.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:

北京市石景山区鲁谷路33号 

研究负责人通讯地址:

北京市石景山区鲁谷路33号 

Applicant address:

33 Lugu Road, Shijingshan District, Beijing, China  

Study leader's address:

33 Lugu Road, Shijingshan District, Beijing, China  

申请注册联系人邮政编码:

Applicant postcode:

100040 

研究负责人邮政编码:

Study leader's postcode:

100040 

申请人所在单位:

中国中医科学院眼科医院 

Applicant's institution:

Eye Hospital, China Academy of Chinese Medical Sciences 

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:

YKEC-KT-2020-009 

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:

中国中医科学院眼科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Eye Hospital, China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-12 

伦理委员会联系人:

张晓敏 

Contact Name of the ethic committee:

Xiaomin Zhang 

伦理委员会联系地址:

北京市石景山区鲁谷路33号 

Contact Address of the ethic committee:

33 Lugu Road, Shijingshan District, Beijing, 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:

中国中医科学院眼科医院 

Primary sponsor:

Eye Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市石景山区鲁谷路33号 

Primary sponsor's address:

33 Lugu Road, Shijingshan District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院眼科医院

具体地址:

石景山区鲁谷路33号

Institution
hospital:

Eye Hospital, China Academy of Chinese Medical Sciences

Address:

33 Lugu Road, Shijingshan District

经费或物资来源:

国家中医药管理局中医药循证能力建设项目 

Source(s) of funding:

National Administration of Traditional Chinese Medicine: Project of Building Evidence Based Practice Capacity for TCM  

研究疾病:

湿性年龄相关性黄斑变性 

Target disease:

Neovascular age-related macular degeneration 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评价明睛颗粒治疗湿性年龄相关性黄斑变性的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Mingjing Granule in the treatment of neovascular age-related macular degeneration. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

① 单眼或双眼符合nAMD诊断标准; ② 符合中医辨证阴虚血瘀证; ③ 年龄在50-80周岁; ④ ETDRS视力表检测最佳矫正视力为73-34个字母(包含边界),相当于Snellen视力表20/40-20/200; ⑤ 同意参加本项研究并签署知情同意书。 

Inclusion criteria

① Exudative changes due to active CNV lesions secondary to AMD in one eye or both eyes. ② Up to the syndrome of TCM: Yin deficiency and blood stasis. ③ Aged 50 to 80 years. ④ The BCVA between 73 and 34 assessed by ETDRS charts(approximately 20/40-20/200 Snellen equivalent). ⑤ Agree to participate in the trial and provide written informed consent. 

排除标准:

①PCV或晚期AMD瘢痕完全形成无出血、渗出者; ②合并高度近视、青光眼、糖尿病视网膜病变、视网膜动静脉阻塞、视神经疾病(视神经炎、视神经萎缩、视乳头水肿)、黄斑裂孔等眼底疾病或其他眼病所致CNV患者;或合并严重心脑血管、肝脏、造血系统疾病,或严重危及生命的原发性疾病、精神病患者; ③屈光间质不清,影响眼科检查者; ④实验室检查血肌酐超过正常值上限;ALT、AST超出正常值范围2倍以上; ⑤正在参加其他药物临床试验,或合并使用同类药物和其他疗法(3个月内接受过抗VEGF治疗、激素治疗、激光治疗以及眼科手术等); ⑥根据研究者判断,具有降低入组可能性或使入组复杂化的其他病变或情况,如生活环境不稳定等易造成失访的情况。 

Exclusion criteria:

①Those with PCV or complete scars due to AMD but without bleeding or exudation. ②Those with high myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, retinal artery occlusion, optic neuropath (optic neuritis, atrophy, papillary edema), macular hole or CNV due to other ocular fundus diseases; or with severe diseases in cardio-cerebrovessels, liver, hematopoietic systems, or severely life-threatening primary diseases or mental illness. ③Unclear dioptric media in the study eye that affecting ocular fundus examination. ④Those with creatinine the upper limit of normal, AST and/or ALT 2-fold the upper limitation of normal or above. ⑤Previous or concomitant participation in another clinical study with investigational medicinal products or combined with similar Chinese medicine or other therapies(prior treatment of the study eye with intraocular anti-VEGF agents, corticosteroids, laser, eye surgery within 3 months prior to study entry). ⑥Patients who the investigators deem to be ineligible for the study, such as unstable living environment, which may lead to loss of follow-up. 

研究实施时间:

Study execute time:

From2019-05-01To 2022-05-31 

征募观察对象时间:

Recruiting time:

From2020-10-01To 2021-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

90

Group:

Test group

Sample size:

干预措施:

明睛颗粒+雷珠单抗

干预措施代码:

Intervention:

Mingjing Granule + ranibizumab

Intervention code:

组别:

对照组

样本量:

90

Group:

Control group

Sample size:

干预措施:

安慰剂+雷珠单抗

干预措施代码:

Intervention:

Placebo + ranibizumab

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

佛山 

Country:

China 

Province:

Guangdong 

City:

Foshan 

单位(医院):

佛山市中医院 

单位级别:

三级甲等 

Institution
hospital:

Foshan Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市中医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

河南省中医院(河南中医药大学第二附属医院) 

单位级别:

三级甲等 

Institution
hospital:

Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

辽宁中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东中医药大学附属医院(山东省中医院) 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine(Shandong Province Hospital of Traditional Chinese Medicine)  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

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:

黄斑中央视网膜厚度

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:

视网膜出血、渗出面积

指标类型:

次要指标 

Outcome:

Area of retinal hemorrhage and exudation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候量表评分

指标类型:

次要指标 

Outcome:

TCM syndrom score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

雷珠单抗注射总次数

指标类型:

次要指标 

Outcome:

The number of intravitreal ranibizumab injections

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗总费用

指标类型:

次要指标 

Outcome:

Total cost of the treatment

Type:

Secondary 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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 80 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):

采用区组随机化方法,随机序列表由中国中医科学院临床药理研究所运用 SAS 9.4 软件在计算机上模拟产生,受试者将以1:1随机分配到两组中的一组。

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

Randomization method : randomized block. Random sequence table will be generated by SAS version 9.4, and performed by Institute of Clinical Pharmacology, China Academy of Chinese Medical Sciences. Participants will be allocated randomly into one of the two groups with a ratio of 1:1.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

学术会议和同行评审期刊

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

Academic conferences and peer-reviewed journals.

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:

病例记录表,电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-08-21
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