中西医结合治疗视网膜中央静脉阻塞黄斑水肿疗效评价

注册号:

Registration number:

ITMCTR2022000018

最近更新日期:

Date of Last Refreshed on:

2022-06-24

注册时间:

Date of Registration:

2022-06-17

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

中西医结合治疗视网膜中央静脉阻塞黄斑水肿疗效评价

Public title:

Evaluation of the therapeutic effect of integrated traditional Chinese and western medicine on macular edema of central retinal vein occlusion

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中西医结合治疗视网膜中央静脉阻塞黄斑水肿疗效评价

Scientific title:

Evaluation of the therapeutic effect of integrated traditional Chinese and western medicine on macular edema of central retinal vein occlusion

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200061397 ; ChiMCTR2200006205

申请注册联系人:

谢立科

研究负责人:

谢立科

Applicant:

Xie Like

Study leader:

Xie Like

申请注册联系人电话:

Applicant telephone:

13466782818

研究负责人电话:

Study leader's telephone:

13466782818

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:

bjxielike@sina.com

研究负责人电子邮件:

Study leader's E-mail:

bjxielike@sina.com

申请单位网址(自愿提供):

Study leader's 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号中国中医科学院眼科医院

研究负责人通讯地址:

北京市石景山区鲁谷路33号中国中医科学院眼科医院

Applicant address:

33 Lugu Road, Shijingshan District, Beijing. eye hospital of China Academy of Chinese Medical Sciences

Study leader's address:

33 Lugu Road, Shijingshan District, Beijing. eye hospital of China Academy of Chinese Medical Sciences

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:

中国中医科学院眼科医院

Applicant's institution:

Eye hospital of China Academy of Chinese Medical Sciences

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

YKEC-KT-2022-024-P002

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院眼科医院伦理委员会

Name of the ethic committee:

Ethics Committee of Eye hospital of Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2022/6/13 0:00:00

伦理委员会联系人:

张晓敏

Contact Name of the ethic committee:

Zhang XiaoMin

伦理委员会联系地址:

北京市石景山区鲁谷路33号中国中医科学院眼科医院

Contact Address of the ethic committee:

33 Lugu Road, Shijingshan District, Beijing, China Academy of Chinese Medical Sciences Eye Hospital

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 6868 8877 to 5589

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 of Chinese 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

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):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国中医科学院

具体地址:

北京市东城区东直门内南小街16号

Institution
hospital:

Chinese Academy of Chinese Medical Sciences

Address:

16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing

经费或物资来源:

中国中医科学院科技创新重大公关项目

Source(s) of funding:

China Academy of Traditional Chinese Medicine Science and Technology Innovation Major Public Relations Project

研究疾病:

视网膜中央静脉阻塞黄斑水肿

研究疾病代码:

Target disease:

Retinal vein occlusion-macular edema

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

病例对照研究

Case-Control study

研究所处阶段:

Study phase:

I期临床试验

Phase I clinical trial

研究目的:

观察祛积通络方联合抗VEGF药物治疗视网膜中央静脉阻塞黄斑水肿的临床疗效

Objectives of Study:

To observed the clinical effect of quprescription and anti-VEGF on macular edema of central retinal vein obstruction.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)年龄在 30~75周岁之间; (2)符合诊断标准中的视网膜中央静脉阻塞黄斑水肿的西医诊断标准以及痰瘀互结证中医证候诊断标准; (3)自愿入组参加项目研究且依从性好的患者。

Inclusion criteria

(1) Age: 30 and 75 years old; (2) Meet the diagnostic criteria for western medicine diagnosis of macular edema of central retinal vein obstruction in the diagnostic criteria and the diagnostic criteria of sputum and blood stasis syndrome syndrome; (3) Patients who voluntarily participate in the project study and have good compliance.

排除标准:

(1)合并有角膜炎、眼内炎等活动性细菌、病毒、真菌感染病变; (2)合并黄斑裂孔、中心性浆液性脉络膜视网膜病变、糖尿病视网膜病变、视网膜色素变性、视网膜脱离等影响视力的眼底疾病; (3)合并屈光间质混浊,无法完成FFA或OCT等检查者; (4)全身或眼部条件不适合进行房水抽取检测者; (5)对雷珠单抗、荧光素钠造影剂过敏,或对祛积通络方中的组成成分过敏者; (6)患有严重心、脑、肝、肾、血液系统等全身疾病者; (7)合并有神经、精神疾患,无法合作或不愿合作者; (8)妊娠、哺乳期妇女或近期有生育计划者; (9)入选前3个月参加过其它临床试验,或研究者认为不宜参与本试验的其他情况者。

Exclusion criteria:

(1) Combined with keratitis, endophthalmitis and other active bacteria, viruses, fungal infections; (2) With macular hole, central serous chororetinopathy, diabetic retinopathy, retinopathy, retinal pigmentosa, and other fundus diseases affecting retinal detachment; (3) Combined with the refractive interstitial turbidity, and unable to complete the FFA or OCT inspection; (4) Whole-body or eye conditions are not suitable for room water extraction and testing; (5) Allergic to leezumab, fluorescein sodium contrast agent, or allergic to the components of the formula; (6) Suffering from serious heart, brain, liver, kidney, blood system and other systemic diseases; (7) With neurological and mental disorders, unable to cooperate or unwilling to cooperate; (8) Pregnant or lactating women or those with recent family plans; (9) Those who have participated in other clinical trials 3 months before selection, or other circumstances that the investigator considers unsuitable to participate in this trial.

研究实施时间:

Study execute time:

From 2022-07-01

To      2024-05-31

征募观察对象时间:

Recruiting time:

From 2022-07-01

To      2024-01-01

干预措施:

Interventions:

组别:

治疗组

样本量:

31

Group:

Treatment group

Sample size:

干预措施:

玻璃体腔注射雷珠单抗注射液联合“祛积通络方颗粒剂”

干预措施代码:

Intervention:

Intravitreal injection of rizumab injection combined with Quji Tongluo decoction.

Intervention code:

组别:

对照组

样本量:

31

Group:

Control group

Sample size:

干预措施:

玻璃体腔注射雷珠单抗注射液联合安慰剂

干预措施代码:

Intervention:

Intravitreal injection of rizumab injection combined with placebo

Intervention code:

样本总量 Total sample size : 62

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国中医科学院眼科医院

单位级别:

三甲

Institution/hospital:

Eye hospital of Chinese Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

黄斑区血流密度、视盘血流检测

指标类型:

次要指标

Outcome:

Detection of blood flow density and optic disc blood flow in the macular area

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标

Outcome:

routine urine test

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

routine blood test

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄斑中心凹厚度

指标类型:

主要指标

Outcome:

Macular foveal thickness

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼部并发症(眼压异常、眼内炎发生率)

指标类型:

副作用指标

Outcome:

Eye complications

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化检查(肝肾功能)

指标类型:

副作用指标

Outcome:

Biochemical examination

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最佳矫正视力

指标类型:

次要指标

Outcome:

Best-corrected visual acuity examination

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

房水代谢组学检查

指标类型:

次要指标

Outcome:

Metabolomics examination of aqueous humor

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候评分

指标类型:

次要指标

Outcome:

Traditional Chinese medicine syndrome 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:

眼底照相检查

指标类型:

次要指标

Outcome:

Fundus photo examination

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标

Outcome:

electrocardiogram

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物过敏反应

指标类型:

副作用指标

Outcome:

hypersensitivity reaction of drug

Type:

Adverse events

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:

房水

组织:

Sample Name:

aqueous humor

Tissue:

人体标本去向

使用后销毁

说明

代谢组学检测

Fate of sample 

Destruction after use

Note:

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

安全性评估

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 30
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

Random number table

盲法:

Blinding:

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):

不共享原始数据

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

no

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

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

case record form

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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