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【ChiCTR-ICR-15006619】比效玻璃體注射類固醇(triamcinolone acetonide)及抗血管內皮生長因子藥物(ranibizumab)聯合療法和單一注射抗血管內皮生長因子藥物(ranibizumab)治療新生血管老年性黃斑病變之療效及安全性的前膽性研究

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基本信息

登记号

ChiCTR-ICR-15006619

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2015-06-17

临床申请受理号

靶点

适应症

triamcinolone acetonide, ranibizumab, neovascular age-related macular degeneration

试验通俗题目

比效玻璃體注射類固醇(triamcinolone acetonide)及抗血管內皮生長因子藥物(ranibizumab)聯合療法和單一注射抗血管內皮生長因子藥物(ranibizumab)治療新生血管老年性黃斑病變之療效及安全性的前膽性研究

试验专业题目

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

试验分类

试验类型

随机平行对照

试验分期

治疗新技术

随机化

Randomized

盲法

Single-blind

试验项目经费来源

Novartis Pharmaceuticals (HK) Ltd.

试验范围

目标入组人数

实际入组人数

第一例入组时间

2015-06-30

试验终止时间

1990-01-01

是否属于一致性

入选标准

1. Patients with active subfoveal CNV of all types (including predominantly classic, minimally classic, occult, and retinal angiomatous proliferation) secondary to AMD; 2. Age beyond 50 years old; 3. Only one eye are suffering from CNV; 4. Best-corrected visual acuity (BCVA) between 20/32 and 20/320 measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) charts; 5. Lesions do not exceed 12 disk areas; 6. No more than 50% of the lesions could be occupied by subretinal hemorrhage; 7. Pseudophakic eyes; 8. Patients can give consent.；

排除标准

1. Eyes with subfoveal fibrosis or atrophy, retinal pigment epithelial tear involving the macula, or subretinal hemorrhage involving the center of the fovea (>50% of the total CNV area); 2. Eyes have been treated for AMD with intraocular anti-VEGF therapy or are previous treatment with verteporfin photodynamic therapy or laser photocoagulation within the past 3 months; 3. Intraocular surgery within the past 2 months or likely to be performed during the study period; 4. Documented diabetic retinopathy, uncontrolled glaucoma, and CNV not related to AMD; 5. History or presence of intraocular inflammation or infection; 6. History of glaucoma and on more than one topical medication; 7. History of glaucoma filtering surgery in the study eye; 8. Family history of glaucoma.；

研究者信息

研究负责人姓名

试验机构

Department of Ophthalmology and Visual Sciences, 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

联系人通讯地址

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