A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 593
- 主要终点
- Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
研究概览
简要总结
The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated
详细描述
The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.
Patients will be followed up for a period of 48 months or until it is no longer possible
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
- •Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
- •Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
- •Man or woman aged 18 years or more
- •Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;
排除标准
- •Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
- •Patient who does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
- •Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
- •Patient taking part in an interventional study at the time of enrolment.
研究组 & 干预措施
Cohort 1
According to the recommendations of the Summary of Product Characteristics (SmPC)
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
时间窗: Baseline to 12 months
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
次要结局
- Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit(Baseline to 2 year, 3 year, 4 year)
- Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)(Baseline to 1 year, 2 year, 3 year, 4 year)
- Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit(Baseline to 1 year, 2 year, 3 year, 4 year)