NCT06178770已完成不适用
Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts
研究概览
简要总结
This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.
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
- •Patients with a diagnosis of nAMD.
- •Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
- •Patients remained on brolucizumab for at least 12 months.
- •Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
- •For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
- •For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.
排除标准
- •For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
- •Eyes missing bilaterality information in their nAMD diagnosis.
- •Eyes missing bilaterality information in their brolucizumab injections.
结局指标
主要结局
Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts
时间窗: Baseline, Month 12
次要结局
- Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)(Baseline, Month 12 and Month 18)
- Anti-VEGF treatment status(Baseline)
- Last injection interval before switch to brolucizumab in prior-treated eyes(Baseline)
- Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection(Up to 3 years)
- Pigment epithelial detachment (PED)(Baseline)
- Gender(Baseline)
- Central macular thickness (CMT)(Baseline, Month 12 and Month 18)
- Subretinal fluid (SRF)(Baseline)
- Median time (days) from AE to resolution(Up to 3 years)
- Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)(Baseline, Months 12 and 18)
- Age(Baseline)
- Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts(Baseline, Month 18)
- Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)(Baseline, Months 12 and 18)
- Intraretinal fluid (IRF)(Baseline)
- Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)(Baseline, Month 12)
- Proportion of patients in different levels of vision recovery after AE resolution(Up to 3 years)
- Median time (days) from first brolucizumab injection to AE(Up to 3 years)
- Median time (days) from last brolucizumab injection pre-AE to AE(Up to 3 years)
- Median number of brolucizumab injections pre-AE including the index injection(Up to 3 years)
研究者
研究点 (1)
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