Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular 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
- 330
- 试验地点
- 1
- 主要终点
- Last injection interval in the 2nd year of treatment
研究概览
简要总结
In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision.
The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed.
The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old.
All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following:
- the number of aflibercept eye injections the patients received
- how long the patients could wait between treatments
- the change in the patients' vision
- how many patients stopped treatment and why.
- associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.
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
- •Adult (≥18 years) patients diagnosed with nAMD
- •Anti-VEGF treatment-naïve
- •Started Intravitreal (IVT) aflibercept treatment between 01 January 2016 and 30 November 2018
- •Aflibercept treatment according to Treat-and-Extend (T&E) immediately after the loading dose
- •Availability of medical records of aflibercept treatment.
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice during the aflibercept treatment
- •Patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.
研究组 & 干预措施
Cohort 1
Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye.
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Last injection interval in the 2nd year of treatment
时间窗: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Number of injections in the first 24 months of treatment
时间窗: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
次要结局
- Last injection interval in the 1st, 3rd and 4th year(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of patients discontinuing aflibercept treatment after 24 months(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Reason for discontinuation of aflibercept treatment after 24 months(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED)(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of monitoring visits during each year of the study(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of patients discontinuing aflibercept treatment within the first 24 months(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Reason for discontinuation of aflibercept treatment during first 24 months(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of aflibercept injections during the 1st, 3rd and 4th year of treatment(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)
- Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)(Retrospective analysis from 01-Jan-2016 to 30-Nov-2020)