NCT01136252已完成2 期
Open-label Clinical Trial to Evaluate Safety and Efficacy of Intravitreal Adalimumab in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Non-responders to the Conventional Treatment With Ranibizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Patients proportion with electroretinogram alterations
研究概览
简要总结
Adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. This study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.
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
- •Choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months
排除标准
- •Only one functional eye
- •Hypersensitivity to adalimumab or any component of the formulation
- •Previous systemic treatment with adalimumab
- •Life expectancy <1 year
研究组 & 干预措施
Adalimumab
Experimental
干预措施: Adalimumab (Drug)
结局指标
主要结局
Patients proportion with electroretinogram alterations
时间窗: 6 months
次要结局
- Changes in retinal thickness measured by ocular coherence tomography(once a month to 6 months)
- Changes in best corrected visual acuity(once a month to 6 months)
- Incidence of adverse events(until 6 months)
研究者
研究点 (1)
Loading locations...
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