今天是:2020-09-23 星期三

糖尿病性视网膜病变患者应用抗VEGF治疗意愿调查问卷
下载XML文档

注册号:

Registration number:

ChiCTR1900027491 

最近更新日期:

Date of Last Refreshed on:

2019-11-15 

注册时间:

Date of Registration:

2019-11-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

糖尿病性视网膜病变患者应用抗VEGF治疗意愿调查问卷 

Public title:

Intention survey of anti-VEGF treatment on patients with Diabetic Retinopathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

糖尿病性视网膜病变患者应用抗VEGF治疗意愿调查问卷 

Scientific title:

Intention survey of anti-VEGF treatment on patients with Diabetic Retinopathy 

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:

刘翠琴 

研究负责人:

孔珺 

Applicant:

Cuiqin Liu 

Study leader:

Jun Kong 

申请注册联系人电话:

Applicant telephone:

+86 021 64705530 

研究负责人电话:

Study leader's telephone:

+86 13066521123 

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:

sci@both-win.net 

研究负责人电子邮件:

Study leader's E-mail:

kongjun@hotmail.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:

上海市徐汇区浦北路7号中星城602室 

研究负责人通讯地址:

辽宁省沈阳市皇姑崇山东路4号 

Applicant address:

Room 602, Z Star Plaza, 7 Pubei Road, Xuhui District, Shanghai, China  

Study leader's address:

4 Chongshan Road East, Huanggu District, Shenyang, Liaoning, 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:

上海博征商务咨询有限公司 

Applicant's institution:

Bothwin Pte. Ltd. 

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:

EC-2019-KS-050 

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伦理委员会 

Name of the ethic committee:

The Ethics Committee of the Fourth Affiliated Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-26 

伦理委员会联系人:

金元哲 

Contact Name of the ethic committee:

YuanZhe Jin 

伦理委员会联系地址:

辽宁省沈阳市皇姑崇山东路4号 

Contact Address of the ethic committee:

4 Chongshan Road East, Huanggu District, Shenyang, Liaoning, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 024-62571549 

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 Fourth Affiliated Hospital of China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市皇姑区崇山东路4号 

Primary sponsor's address:

4 Chongshan Road East, Huanggu District, 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:

皇姑区崇山东路4号

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University

Address:

4 Chongshan Road East, Huanggu District

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):

中国医科大学第一附属医院

具体地址:

和平区南京北街155号

Institution
hospital:

The First Hospital of China Medical University

Address:

155 Nanjing Street North, Heping District

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

哈尔滨医科大学附属第一医院眼科医院

具体地址:

南岗区一曼街 141号

Institution
hospital:

Ophthalmic Hospital of the First Affiliated Hospital of Harbin Medical University

Address:

141 Yiman Street, Nangang District

国家:

中国

省(直辖市):

辽宁

市(区县):

大连

Country:

China

Province:

Liaoning

City:

Dalian

单位(医院):

大连医科大学附属第二医院

具体地址:

沙河口区中山路467号

Institution
hospital:

The Second Hospital of Dalian Medical University

Address:

467 Zhongshan Road, Shahekou District

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):

沈阳市第四人民医院

具体地址:

皇姑区黄河南大街20号

Institution
hospital:

The Forth People's Hospital of Shenyang

Address:

20 Huanghe South Street, Huanggu District

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):

中国医科大学附属盛京医院

具体地址:

和平区三好街36号

Institution
hospital:

Shengjing Hospital of China Medical University

Address:

36 Sanhao Street, Heping District

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):

沈阳爱尔卓越眼科医院有限公司

具体地址:

南京北街272号

Institution
hospital:

Aier Excellence Eye Hospital Co. Ltd.

Address:

272 Nanjing Street North

国家:

中国

省(直辖市):

辽宁

市(区县):

抚顺

Country:

China

Province:

Liaoning

City:

fushun

单位(医院):

抚顺市眼病医院

具体地址:

新抚区琥珀街1号

Institution
hospital:

Fushun Eye Hospital

Address:

1 Hupo Street, Xinfu District

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

shanghai

City:

单位(医院):

上海博征商务咨询有限公司

具体地址:

徐汇区浦北路7号中星城602室

Institution
hospital:

Bothwin Pte.Ltd.

Address:

Room 602, Z Star Plaza, 7 Pubei Road, Xuhui District

经费或物资来源:

无 

Source(s) of funding:

NO 

研究疾病:

糖尿病性视网膜病变 

Target disease:

Diabetic Retinopathy 

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:

其它 

Study phase:

N/A 

研究目的:

糖尿病性视网膜病变是糖尿病性微血管病变中最严重的并发症之一,血糖控制情况对糖尿病性视网膜病变的发生发展有着重要影响,不及时治疗最终可致失明。黄斑水肿是糖尿病性视网膜病变的一个常见表现,是导致糖尿病患者视力严重损害的重要因素之一。 在70年代末,80年代初,应用即时全视网膜激光光凝(PRP)已成为治疗糖尿病性视网膜病变的主要手段,但是另一方面,经过PRP治疗的患者,会有严重的周边视野缺损;五年内高达38%的病人可发生糖尿病性黄斑水肿;并且50%的患者需要接受二次PRP治疗;此外,PRP对Ⅰ型糖尿病患者治疗效果欠佳,对视乳头新生血管的消退效果欠佳;甚至五年内近50%的患者会发生玻璃体出血,五年内视网膜脱离的发生率10-18%。自1985年始,局灶光凝/格栅光凝作为糖尿病性黄斑水肿的主要治疗手段,对减轻黄斑水肿、提高视力、减少严重视力丧失具有重要意义。但与此同时,局灶光凝/格栅光凝术后仍有约1/5的患者视力下降≥两行视力表。 随着医学的进步,抗VEGF药物的诞生给治疗糖尿病性视网膜病变及黄斑水肿带来新的希望。本项目旨在调查糖尿病性视网膜病变患者对应用玻璃体腔注射抗VEGF药物治疗方案的意愿,尤其在中国,没有医保的情况下,糖尿病性视网膜病变患者对应用玻璃体腔注射抗VEGF药物的接受程度。从而指导我们有针对性的对患者进行治疗方案的选择。 

Objectives of Study:

In the late 1970s and early 1980s, the application of prompt panretinal photocoagulation (PRP) became the primary therapy for diabetic retinopathy. It can effectively prevent patients with DR from being blind. But on the other hand, patients treated with PRP have severe peripheral visual field defects and up to 38% of patients can develop diabetic macular edema within five years and 50% of patients may require secondary PRP therapy within a year. In addition, PRP is not effective in treating patients with type 1 diabetes and has less regressive effect on neovascularization of the disc (NVD). A large randomized double-blind clinical trial, Protocol S, from DRCRnet, showed that about 50% of DR patients who received PRP developed at least one time vitreous hemorrhage within 5 years, and 16% patients in the PRP arm experienced retinal detachment. Since 1985, focal/grid laser photocoagulation had been the main treatment for diabetic macular edema, which was of great significance in relieving macular edema, improving visual acuity and reducing severe vision loss compared with no treatment. However, there were about one-fifth patients went through visual acuity reduction by two lines of eye chart after focal /grid laser photocoagulation treatment, and there were about one third patients had visual acuity reduction at different levels. With the development in medicine, anti-VEGF agents bring new hope for diabetic retinopathy and macular edema treatment. The purpose of this study is to investigate the willingness of receiving intravitreal injection of anti-VEGF agents in Chinese patients with diabetic retinopathy, a cohort that the anti – VEGF drugs cant be covered by health insurance. This study can provide physicians with guidance on choosing personalized treatment regimen for patients with diabetic retinopathy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 糖尿病性视网膜病变伴黄斑水肿的患者; 2. 增殖型糖尿病性视网膜病变不伴有黄斑水肿的患者。 

Inclusion criteria

1.Patients with diabetic retinopathy and macular edema. 2.Patients with proliferative diabetic retinopathy without macular edema. 

排除标准:

严重玻璃体积血不能吸收,视网膜脱离,视网膜前大量增殖膜,需要手术治疗的患者。 

Exclusion criteria:

Patients with severe vitreous hemorrhage that cannot be absorbed, retinal detachment, severe preretinal proliferative membrane, who require surgical treatment. 

研究实施时间:

Study execute time:

From2019-12-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-12-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case Series

样本量:

300

Group:

Case Series

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

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:

三甲医院 

Institution
hospital:

the fourth affiliated hospital of china medical university  

Level of the institution:

Level A Tertiary Hospital 

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):

中国医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The first hospital of china medical university  

Level of the institution:

Level A Tertiary Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属第一医院眼科医院 

单位级别:

三甲医院 

Institution
hospital:

Ophthalmic hospital of the first Affiliated hospital of harbin medical university  

Level of the institution:

Level A Tertiary Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连医科大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

the second hospital of dalian medical university  

Level of the institution:

Level A Tertiary Hospital 

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):

沈阳市第四人民医院 

单位级别:

三甲医院 

Institution
hospital:

The forth people’s hospital of Shenyang  

Level of the institution:

Level A Tertiary Hospital 

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):

中国医科大学附属盛京医院 

单位级别:

三甲医院 

Institution
hospital:

Shengjing hospital of china medical university  

Level of the institution:

Level A Tertiary Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

抚顺 

Country:

China 

Province:

Liaoning 

City:

fushun 

单位(医院):

抚顺市眼病医院 

单位级别:

二甲 

Institution
hospital:

Fushun Eye Hospital  

Level of the institution:

two A hospital 

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):

沈阳爱尔卓越眼科医院有限公司 

单位级别:

三甲医院 

Institution
hospital:

Aier Excellence Eye Hospital Co. Ltd  

Level of the institution:

Level A Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

治疗意愿

指标类型:

主要指标 

Outcome:

treatment intention

Type:

Primary indicator 

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

questionnaire investigation

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 years
最大 Max age 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):

所有目标发放调研问卷,不存在随机方法。

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

N/A

盲法:

N/A

Blinding:

N/A

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

临床试验公共管理平台:http://www.medresman.org.cn

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

ResMan, http://www.medresman.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:

1)研究人员邀请符合条件的患者参加研究并验证不具有排除标准。参加本研究的患者将分配一个数字代码。 2)研究者向参与者充分讲解问卷调查二,讲解DME的现状,向参与者进行抗VEGF及PRP、局灶光凝/格栅光凝治疗糖尿病性视网膜病变的现状分析。 3)参与者填写完成问卷调查一。

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

1. The researchers will invite eligible patients to participate in the study and verify they don’t meet the exclusion criteria. Patients participating in this study will be assigned a numeric code to protect their privacy. 2. The participants will complete questionnaire I by themselves. 3. The researchers will fully explain the questionnaire, what is diabetic macular edema and the bright sides and downsides of anti-VEGF, PRP and local photocoagulation/grid photocoagulation treatment for diabetic retinopathy. Then, the participants will be asked to fill in the questionnaire II.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-15
返回列表