Intravitreal Aflibercept in Neovascular Age-related Macular Degeneration (nAMD): an Observational Study Assessing Patient Relevant Outcomes, Real-world Treatment Pattern and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- Reasons why a patient failed to appear to a scheduled injection visit
研究概览
简要总结
In this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of Aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). The study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. They want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 neovascular age-related macular degeneration
- •Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice or current treatment with IVT-AFL (all prior anti-VEGF treatments must have been applied by the participating study site)
- •No participation in an investigational program with interventions outside of routine clinical practice
- •No contra-indications according to the local marketing authorization/ Summary of Product Characteristics (SmPC)
- •Ability and willingness to participate in telephone interviews
排除标准
- •Any prior therapy with intravitreal steroids in the study eye.
- •Concomitant therapy (except nutritional supplements) with any other agent to treat nAMD in the study eye
- •Any prior transpupillary thermotherapy, photodynamic therapy, macular rotation/ translocation or macular laser in the study eye or
- •Structural damage to the center of the macula in either eye
- •Any other condition expected to permanently limit visual acuity outcomes over the course of the study
研究组 & 干预措施
Patients with nAMD_Treatment-naive (anti-VEGF naive)
Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
干预措施: Ivt. Aflibercept (Eylea, BAY86-5321) (Drug)
Patients with nAMD_Pre-treated with IVT-AFL
Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
干预措施: Ivt. Aflibercept (Eylea, BAY86-5321) (Drug)
Patients with nAMD_Pre-treated with any anti-VEGF
Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
干预措施: Ivt. Aflibercept (Eylea, BAY86-5321) (Drug)
结局指标
主要结局
Reasons why a patient failed to appear to a scheduled injection visit
时间窗: Up to 24 months
Asked in telephone interviews
Time to first appearance of non-consistence
时间窗: Up to 24 months
Non-consistence is: * Failure of subjects to appear to a scheduled injection visit; * Strong time deviation of injections from approved aflibercept posology.
次要结局
- Reasons for therapeutic switching(At 12 and 24 months)
- Change in treatment satisfaction(From 4 month to 12 and 24 months)
- Vision-specific quality of life by NEI VFQ-25(At baseline, 4, 12 and 24 months)
- Reasons for treatment discontinuation(At 4, 12 and 24 months)
- Percentage of consistently treated patients(At 12 and 24 months)
- Change in best corrected visual acuity (BCVA) letters(From baseline to 4, 12 and 24 months)
- Change in vision-specific quality of life(From baseline to 4, 12 and 24 months)
- Information about disease and treatment(At 4, 12 and 24 months)
- Willingness to continue therapy(At 4, 12 and 24 months)
- Average time between injections in the study eye(Up to 24 months)
- Number of injections in the study eye per year(Up to 24 months)
- Number of injections until start of observation(At baseline)
- Type of treatment until start of observation(At baseline)
- Burden of therapy(At 4, 12 and 24 months)
- Change in general quality of life by EQ-5D(From baseline to 12 and 24 months)
- Percentage of patients receiving 3 initial monthly injections(Up to 24 months)
- Proportion of patients undergoing therapeutic switch(At 12 and 24 months)
- Average time between visits(Up to 24 months)
- Number of visits in clinics/ ophthalmology practices other than the study center per year(Up to 24 months)
- Change in central retinal thickness (CRT)(From baseline to 4, 12 and 24 months)
- Treatment satisfaction by MAC-TSQ(At 4, 12 and 24 months)
- Proportion of patients discontinuing disease monitoring at participating center(At 12 and 24 months)
- Number of visits per study eye per year(Up to 24 months)
- Duration of treatment until start of observation(At baseline)
- Percentage of non-persistent patients(At 12 and 24 months)
- Time from baseline to first instance of non-persistence(Up to 24 months)
- Number of examinations of the study eye per year(Up to 24 months)