NCT02321839已完成4 期
Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.
详细描述
Treat and Extend Regimen (TER) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. Therefore, we have planned to examine the psychological impact of TER using Hospital Anxiety and Depression Scale (HADS), in addition to the improvement of visual acuity and central retinal thickness.
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
- •Signed informed consent form
- •Male or female of aged 50 years or older
- •Typical AMD and PCV patients
- •BCVA of 24 letters or over
排除标准
- •Total lesion area of >12 DA or >30.5 mm2
- •The existence of subretinal hemorrhage area constituting ≥50% of total lesion area
- •The existence of scar or fibrosis area constituting ≥50% of total lesion area
- •The existence of RPE tear
- •Prior treatment for wet AMD
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- •The pregnant or lactating woman
研究组 & 干预措施
Intraviteal Ranibizumab 0.5mg
Experimental
Intraviteal Ranibizumab 0.5mg
干预措施: Intraviteal Ranibizumab 0.5mg (Drug)
结局指标
主要结局
Visual acuity
时间窗: One Year
次要结局
- central foveal thickness(One and two years)
研究者
Yuichiro Ogura
Professor
Nagoya City University
研究点 (2)
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