Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Height (Amplitude) of Multifocal ERG Signal
研究概览
简要总结
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.
详细描述
The functional changes of the retina can be recorded by an electroretinography (ERG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45 years and above
- •Clinical diagnosis of wet AMD
- •First injection of ranibizumab protocol
- •Best corrected visual acuity 20/32 - 20/320
- •Consent form obtained
排除标准
- •Previously treated wet AMD patients
- •Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
- •Pregnancy
- •History of seizure
结局指标
主要结局
Height (Amplitude) of Multifocal ERG Signal
时间窗: baseline, 3 months
Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.
Time to Response (Implicit Time) of Multifocal ERG Signal
时间窗: baseline, 3 months
Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.
次要结局
- Postoperative Complication(1 month)