A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
- •Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye
排除标准
- •Evidence of CNV due to any cause other than nAMD in either eye
- •Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
- •Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
- •Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
- •Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
- •History of vitreoretinal surgery (including scleral buckling) in the study eye
- •Any other intraocular surgery within 12 weeks (84 days) before the screening visit
- •History of corneal transplant or corneal dystrophy in study eye
- •NOTE: Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
intravitreal aflibercept injection (IAI)
Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio
干预措施: aflibercept (Drug)
High-dose aflibercept (HD)
Treatment-naïve patients with nAMD randomized in a 1:1 ratio
干预措施: High-dose aflibercept (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: Up to Week 44
Number of Participants With at Least One Serious TEAE
时间窗: Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
时间窗: At Week 16
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
次要结局
未报告次要终点