Early Anatomical and Functional Changes With Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MPOD and OCT after aflibercept 8 mg loading phase
研究概览
简要总结
Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide.
the central role of vascular endothelial growth factor (VEFG) in the pathogenesis of nAMD has been extensively demonstrated. Since its introduction, intravitreal injection of targeted anti-VEGF antibodies has become the first-line treatment. Aflibercept 8 mg is a new formulation whose efficacy and safety as a new nAMD treatment has been demonstrated in the PULSAR study, emphasising its potential role in reducing the treatment burden in relation to the intended dosing intervals.
The aim of this study is to investigate early anatomical and functional changes in naïve nAMD patients treated with 8 mg aflibercept compared to patients treated with 2 mg aflibercept using OCT and MPOD, as potential parameters for functional outcome. To our knowledge, this is the first study to investigate these changes and the efficacy of aflibercept 8 mg as a potential fast-drying anti-VEGF treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •age over 50 years; diagnosis of naïve nAMD due to the presence of active type 1 macular neovascularization (MNV)
排除标准
- •previous ocular surgery, history of vitreoretinal and/or retinal vascular diseases, uveitis, myopia over 6 dioptres, significant corneal and/or lens opacity, glaucoma, ocular MNV related to other causes than nAMD, geographic atrophy, subretinal fibrosis, previous treatments for MNV
结局指标
主要结局
MPOD and OCT after aflibercept 8 mg loading phase
时间窗: 7 months
The parameters analyzed by OCT and MPOD 4 months after the treatment are: OCT and MPOD.
次要结局
未报告次要终点
研究者
Gilda Cennamo
MD, PhD
Federico II University