NCT02089503Unknown不适用
Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.
Hospital St. Joseph, Marseille, France1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
研究概览
简要总结
Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;
排除标准
- •Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
- •Patients with high myopia or neovessel not related to exudative-ARMD;
结局指标
主要结局
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
时间窗: measured at 24 months (± 4 weeks)
次要结局
- the mean change of the BCVA throughout the 24 months of follow-up (FU),(24 months of follow-up)
研究者
QUEGUINER, MD
Ophtalmologist
Hospital St. Joseph, Marseille, France
研究点 (1)
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