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【ChiCTR-TRC-09000743】The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

基本信息
登记号

ChiCTR-TRC-09000743

试验状态

结束

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2010-05-04

临床申请受理号

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靶点

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适应症

Diabetic macular edema

试验通俗题目

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

试验专业题目

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema - A Pilot Study

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

The Safety and Efficacy of Combined Subtenon Triamcinolone and Grid Laser Photocoagulation as Primary Treatment for Diabetic Macular Edema

试验分类
试验类型

非随机对照试验

试验分期

其它

随机化

NA

盲法

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试验项目经费来源

Department of Ophthalmology and Visual Sciences The Chinese University of Hong Kong

试验范围

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目标入组人数

30

实际入组人数

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第一例入组时间

2007-06-10

试验终止时间

1990-01-01

是否属于一致性

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入选标准

Inclusion criteria: 1. Aged 18 years or older; 2. Clinically significant macular edema (CSME) defined according to the ETDRS; 3. Macular edema of at least 250um involving the fovea, as documented on optical coherent tomogram; 4. Patients with best corrected visual acuity of better than 1.3 ETDRS logMAR units (equivalent to 20/400 on Snellen Chart); 5. Patients physically fit to receive treatment and comply with follow-up schedule; 6. Informed consent.;

排除标准

Exclusion criteria: 1. Ocular diseases other than cataract, diabetic retinopathy and refractive error; 2. Proliferative diabetic retinopathy; 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion more than 6 months prior to enrollment; 5. History of macular laser photocoagulation, intravitreal/ subtenon injection of triamcinolone acetonide or intravitreal injection of any vascular endothelial growth factor inhibitors; 6. History of fluorescein allergy; 7. Fellow eye visual acuity worse than 20/400.;

研究者信息
研究负责人姓名
试验机构

The Chinese University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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