NCT06680817进行中（未招募）不适用
Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 850
- 试验地点
- 108
- 主要终点
- Change in Visual Acuity from Index Date to 12 Months
研究概览
简要总结
The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.
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
- •Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye
- •Patients have received at least one faricimab treatment (the first dose) in the study eye
- •Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)
排除标准
- •Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date
- •Concomitant participation in any interventional clinical study
- •Active ocular inflammation and/or suspected/active ocular infection in either eye
- •Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)
- •Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)
- •Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)
研究组 & 干预措施
Cohort 1: Faricimab for nAMD
This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.
干预措施: Faricimab (Drug)
Cohort 2: Faricimab for DME
This cohort will be divided into two sub-cohorts based on eye treatment history: anti-VEGF treatment naive and anti-VEGF pre-treated.
干预措施: Faricimab (Drug)
结局指标
主要结局
Change in Visual Acuity from Index Date to 12 Months
时间窗: Index Date and 12 months
The index date is defined as the date of the first faricimab treatment injection in the eye.
次要结局
- Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(From Index Date to 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date(Index Date and 3, 6, 12, and 24 months)
- Number of Participants with at Least One Non-Ocular Adverse Event(Approximately 2 years)
- Change in Visual Acuity from Index Date to 3, 6, and 24 Months(Index Date and 3, 6, and 24 months)
- Change in Central Subfield Thickness (CST) from Index Date to 3, 6, 12, and 24 Months(Index Date and 3, 6, 12, and 24 months)
- Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other) Over Time(Index Date and 3, 6, 12, and 24 months)
- Number of Faricimab Intravitreal Injections per Eye per Year(12 and 24 months)
- Number of Faricimab Intravitreal Injections in the Loading Phase for Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(Approximately 4 months)
- Total Number of Visits and Number of Visits With or Without Treatment Over Time(3, 6, 12, and 24 months)
- Cumulative Time Spent in Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(From Index Date to 24 months)
- Percentage of Eyes With Treatment Switch from Faricimab by Reason for Switch in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(3, 6, 12, and 24 months)
- Percentage of Eyes Obtaining Treatment Intervals of Once Every 8, 12, or 16 Weeks or Other Intervals in Participants who are anti-VEGF Treatment Naive or anti-VEGF pre-Treated(12 and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Number of Intravitreal Treatments(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Total Number of Visits(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Treatment Intervals(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Type of anti-VEGF Pre-Treatment and Number of Previous Injections for Preceding Regimen at Index Date(Index Date and 3, 6, 12, and 24 months)
- Change in Visual Acuity from Index Date Over Time, According to Length of Diagnosis of Disease at Index Date(Index Date and 3, 6, 12, and 24 months)
- Number of Participants with at Least One Ocular Adverse Event(Approximately 2 years)
- Number of Participants with at Least One Non-Ocular Adverse Event(Approximately 2 years)
研究者
研究点 (108)
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