NCT02158624Unknown不适用
The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Baseline change of visual acuity and QOL after ranibizumab treatment
研究概览
简要总结
To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
- •Subjects of either gender age 50 years or older
- •Visual acuity better than 0.05 decimal( 20/400 Snellen)
- •Signed informed consent form
排除标准
- •Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
- •Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
- •Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
- •Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
- •Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
- •The pregnant or lactating woman
研究组 & 干预措施
Ranibizumab
Experimental
干预措施: Intravitreal Lucentis 0.5mg (Drug)
结局指标
主要结局
Baseline change of visual acuity and QOL after ranibizumab treatment
时间窗: 3 months
Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.
次要结局
- To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations(1year)
研究者
Yuji Oshima
Assistant professor
Kyushu University
研究点 (1)
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