Review Study: A Retrospective Noninterventional Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 137
- 主要终点
- Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard
研究概览
简要总结
Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of wet Age-related Macular Degeneration
- •Start of anti-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009
- •Informed consent form signed
排除标准
- •Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or device
研究组 & 干预措施
Group 1
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard
时间窗: Baseline and 24 months
次要结局
- Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)(Baseline and 24 months)
- Demographic characteristics of patients included in the study (Age, Sex, Race)(Baseline)
- Mean time from first clinical presentation to diagnosis(Baseline)
- Mean time from diagnosis to treatment(Time from diagnosis to treatment: Up to 24 months)
- Mean time from diagnosis to end of follow-up(Time from diagnosis to end of follow-up: up to 48 months)
- Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart(Baseline and 24 months)
- Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)(Baseline and 24 months)
- Average number of treatments given from diagnosis to end of follow-up(After 24 months)