NCT06439576进行中（未招募）不适用
China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing 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
- 1,000
- 试验地点
- 41
- 主要终点
- Change in Visual Acuity from Baseline at Month 12
研究概览
简要总结
The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving 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
- •Have signed the informed consent
- •Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
- •≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
- •Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
- •Patients have received at least one faricimab treatment (the first dose) in the study eye
排除标准
- •Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
- •Active ocular inflammation or suspected / active ocular infection in either eye
- •Received any other anti-VEGF treatment after faricimab
- •Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
- •Any participation in any other clinical trials currently
- •Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection
研究组 & 干预措施
Cohort 1: Patients with nAMD
干预措施: Faricimab (Drug)
Cohort 3: Patients with RVO
干预措施: Faricimab (Drug)
Cohort 2: Patients with DME
干预措施: Faricimab (Drug)
结局指标
主要结局
Change in Visual Acuity from Baseline at Month 12
时间窗: Baseline and Month 12
Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.
次要结局
- Number of Treatments per Year(Months 12 and 24)
- Number of Visits With or Without Treatment per Year(Months 12 and 24)
- Total Number of Visits per Year(Months 12 and 24)
- Visual Acuity Over Time(Baseline, Months 3, 6, 9, 12, 18, and 24)
- Change in Central Subfield Thickness from Baseline Over Time(Baseline, Months 3, 6, 9, 12, 18, and 24)
- Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time(Months 3, 6, 9, 12, 18, and 24)
- Change in Visual Acuity from Baseline Over Time(Baseline, Months 3, 6, 9, 18, and 24)
- Percentage of Eyes with Treatment Switch by Reason for Switch Over Time(Months 3, 6, 9, 12, 18, and 24)
- Time Interval Between Treatments per Year(Months 12 and 24)
- Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)(From Baseline to Month 24)
- Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24(Months 3, 6, 12, 18, and 24)
- Central Subfield Thickness Over Time(Baseline, Months 3, 6, 9, 12, 18, and 24)
- Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study(From Baseline until end of study (up to 3.5 years))
- Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24(Months 12, 18, and 24)
研究者
研究点 (41)
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