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糖尿病黄斑水肿患者行白内障超声乳化手术联合康柏西普玻璃体腔注射的临床研究
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注册号:

Registration number:

ChiCTR-IIR-15007619 

最近更新日期:

Date of Last Refreshed on:

2015-12-21 

注册时间:

Date of Registration:

2015-12-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

糖尿病黄斑水肿患者行白内障超声乳化手术联合康柏西普玻璃体腔注射的临床研究 

Public title:

clinical research of Conbercept in the therapy of cataract combined with diabetic macular edema  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

糖尿病黄斑水肿患者行白内障超声乳化手术联合康柏西普玻璃体腔注射的临床研究 

Scientific title:

clinical research of Conbercept in the therapy of cataract combined with diabetic macular edema  

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:

陆璐 

研究负责人:

张劲松 

Applicant:

Lu Lu 

Study leader:

Zhang Jinsong 

申请注册联系人电话:

Applicant telephone:

+86 13840369647 

研究负责人电话:

Study leader's telephone:

+86 18900916888 

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:

422134625@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

cmu4h-zjs@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:

辽宁省沈阳市和平区新华路11号 

研究负责人通讯地址:

辽宁省沈阳市和平区新华路11号 

Applicant address:

11 Xinghua Road, Shenyang, Liaoning, China 

Study leader's address:

11 Xinghua Road, Shenyang, Liaoning, China 

申请注册联系人邮政编码:

Applicant postcode:

110000 

研究负责人邮政编码:

Study leader's postcode:

110000 

申请人所在单位:

中国医科大学附属第四医院 

Applicant's institution:

the 4th affiliated hospital of CMU 

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:

2015-028 

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:

中国医科大学附属第四医院医学伦理委员会 

Name of the ethic committee:

medical ethics committee of the 4th affiliated hospital of CMU 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-11-27 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国医科大学附属第四医院 

Primary sponsor:

the 4th affiliated hospital of CMU 

研究实施负责(组长)单位地址:

辽宁省沈阳市和平区新华路11号 

Primary sponsor's address:

11 Xinghua Road, Shenyang, Liaoning, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属第四医院

具体地址:

辽宁省沈阳市和平区新华路11号

Institution
hospital:

the 4th affiliated hospital of CMU

Address:

11 Xinghua Road, Shenyang, Liaoning, China

经费或物资来源:

康柏西普由成都康弘生物科技有限公司提供 

Source(s) of funding:

Conbercepts are provided by the Kanghong biological technology co. 

研究疾病:

白内障合并糖尿病性黄斑水肿 

Target disease:

cataract with diabetic macular edema 

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:

I期临床试验 

Study phase:

研究目的:

评价白内障合并糖尿病黄斑水肿患者在行白内障超声乳化手术同时联合康柏西普玻璃体腔注射治疗的临床有效性及安全性 

Objectives of Study:

to evaluate the efficacy and safety of Conbercept in the therapy of cataract combined with diabetic macular edema 

药物成份或治疗方案详述:

康柏西普眼用注射液 

Description for medicine or protocol of treatment in detail:

Conbercept ophthalmic injection 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

白内障合并糖尿病黄斑水肿患者,白内障晶状体核硬度分级为Ⅲ级的患者,Spectralis OCT检测患者黄斑区中心凹视网膜厚度大于300μm,眼底血管造影显示患者糖尿病性视网膜病变分期为中度、轻度非增生期合并非缺血性黄斑水肿;双眼均符合入选标准者,则由研究者从医学角度确定目标眼;糖化血红蛋白控制标准小于6.5%,餐前血糖低于8mol/L;术前血压不高于160/90mmHg。 

Inclusion criteria

the cataract patients combined with diabetic macular edema, the lens nuclear hardness is in the degree of three, OCT show retinal thickness of macular is greater than 300um, fundus angiography showed that patients with diabetic retinopathy staging is moderate, mild macular edema without ischemic; if both of the eyes are consistent with inclusion criteria, the doctor choose the one eye according to the medical point of view.The control standard of glycosylated hemoglobin was less than 6.5%, the blood glucose was lower than 8mol/L before the meals, and the blood pressure should be less than 160/90mmHg. 

排除标准:

①禁忌行 FFA检查者;②既往曾患其他黄斑病变、老年性黄斑变性、中心性浆液性视网膜病变;③近3个月内有糖皮质激素治疗者以及其他抗VEGF类药物治疗史;④合并有眼前节疾病;⑤合并有严重心、脑、肝、肾和造血系统等疾病;⑥合并有恶性肿瘤者;⑦屈光度大于6D的患者。 

Exclusion criteria:

1. the patient contraindicated to FFA; 2. suffer from other macular diseases previously such as age-related macular degeneration, central serous retinopathy; 3. nearly 3 months were treated with glucocorticoid and other anti VEGF drug treatment; 4. combined with anterior segment disease of eyes; 5. the patients with serious heart, brain and liver kidney and hematopoietic system diseases; 6. the patients with malignant tumor; 7. the diopter is higher than 6D. 

研究实施时间:

Study execute time:

From2015-11-27To 2016-11-27 

征募观察对象时间:

Recruiting time:

From2015-12-13To 2016-12-27 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

experimental group

Sample size:

干预措施:

康柏西普玻璃体腔注射

干预措施代码:

Intervention:

Phacoemulsification for cataract + intravitreal Conbercept injection

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

单纯白内障超声乳化手术

干预措施代码:

Intervention:

Phacoemulsification for cataract

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

中国医科大学附属第四医院 

单位级别:

三甲 

Institution
hospital:

the 4th affiliated hospital of CMU  

Level of the institution:

Tertiary A hospital 

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:

BCVA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

房水蛋白浓度

指标类型:

主要指标 

Outcome:

protein concentration in aqueous humor

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

黄斑区视网膜厚度

指标类型:

主要指标 

Outcome:

retinal thickness of macular

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼压

指标类型:

主要指标 

Outcome:

IOP

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 60 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):

由术者进行区组随机化分组

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

the district group randomized grouping carried out by the operator

盲法:

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):

中国医科大学附属第四医院

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

the 4th affiliated hospital of CMU

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:

中国医科大学附属第四医院

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

the 4th affiliated hospital of CMU

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-12-21
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