INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,312
- 试验地点
- 1
- 主要终点
- Change in Visual Acuity (VA) (Snellen)
研究概览
简要总结
The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.
In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.
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
- •Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.
排除标准
- •Eyes treated previously with another anti-VEGF drug.
研究组 & 干预措施
>= 70 letters
Baseline VA >= 70 letters
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
36-69 letters
Baseline VA 36-69 letters
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
<=35 letters
Baseline VA <=35 letters
干预措施: Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
Change in Visual Acuity (VA) (Snellen)
时间窗: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.
Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
时间窗: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.
Change in Lasbarhetsindex (LIX, Readability Index)
时间窗: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden
次要结局
- Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points(At year 1 and year 2)
- Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)(Up to 2 years)
- Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)(Up to 2 years)
- Proportion of patients with no need of Vision Aid support(Up to 2 years)