A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,126
- 试验地点
- 105
- 主要终点
- Occurrence of serious TEAEs
研究概览
简要总结
This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •for Participants with nAMD:
- •≥50 years of age
- •History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
- •Key Inclusion Criteria for Participants with DME:
- •≥18 years of age
- •History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator
- •Key Inclusion for All Participants:
- •Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1
排除标准
- •for Participants with nAMD:
- •Evidence of CNV due to any cause other than nAMD in either eye
- •Key Exclusion Criteria for Participants with DME:
- •Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
- •Active proliferative diabetic retinopathy (DR) in the study eye
- •NOTE: Other protocol defined inclusion / exclusion criteria apply.
研究组 & 干预措施
Aflibercept 8 mg
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
干预措施: Aflibercept 8 mg (Drug)
结局指标
主要结局
Occurrence of serious TEAEs
时间窗: Through week 24
Occurrence of treatment-emergent adverse events (TEAEs)
时间窗: Through week 24
Participants With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: Through week 24
Participants With at Least One Serious TEAE
时间窗: Through week 24
次要结局
未报告次要终点