Real-World Patient Characteristics, Treatment Patterns, and Outcomes Among Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) Treated With Aflibercept 8 mg in the United States
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 800
- 主要终点
- Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)
研究概览
简要总结
The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration [AMD]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Naïve nAMD
Treatment-naive patients with nAMD
干预措施: aflibercept 8 mg (Drug)
Pretreated nAMD
Patients with nAMD who have been previously treated with anti-VEGF and/or laser
干预措施: aflibercept 8 mg (Drug)
Naïve DME
Treatment-naive patients with DME
干预措施: aflibercept 8 mg (Drug)
Pretreated DME
Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids
干预措施: aflibercept 8 mg (Drug)
结局指标
主要结局
Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)
时间窗: Baseline up to 12 Months
Treatment-Naïve Patient Cohorts
Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study
时间窗: Up to 12 Months
Previously Treated Patient Cohorts: Reported among the subsets of patients (nAMD and DME) treated at dosing intervals of ≤ 8 weeks for ≥ 6 months prior to enrollment
次要结局
- Categorical gains of ≥10 ETDRS letters(Up to 24 Months)
- Change in VA (ETDRS letters)(Baseline up to 24 Months)
- Categorical losses of ≥15 ETDRS letters(Up to 24 Months)
- Treatment interval(Up to 24 Months)
- Categorical gains of ≥5 ETDRS letters(Up to 24 Months)
- Frequency of non-ocular adverse events (AEs)(Up to 24 Months)
- Categorical losses of ≥5 ETDRS letters(Up to 24 Months)
- Categorical losses of ≥10 ETDRS letters(Up to 24 Months)
- Descriptions of study eye characteristics(At Baseline)
- Categorical gains of ≥15 ETDRS letters(Up to 24 Months)
- Proportion of patients achieving 20/40 Snellen equivalent or better(Up to 24 Months)
- Change in Central subfield thickness (CST)(Baseline up to 24 Months)
- Description of demographics(At Baseline)
- Frequency of ocular adverse events (AEs)(Up to 24 Months)
- Missed and unscheduled visits(Up to 24 Months)