A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Vascularized Pigment Epithelial Detachment (V-PED) Secondary to AMD With Serous Component Superior to 50% of the Lesion Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis Treatment as Needed.
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Lesion change as measured with fluorescein angiography.
研究概览
简要总结
This is a pilot, single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed.
详细描述
This study will evaluate the efficacy of IRay treatment in patients with Vascularized Pigment Epithelial Detachment (V-PED) with serous component superior to 50% of the lesion as determined by decreasing the lesion activity; by decreasing the number of Lucentis injections required during the 12 month study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iray plus Lucentis
open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.
干预措施: Iray (Radiation)
Iray plus Lucentis
open label arm in which all subjects receive a single 16 gy dose of radiation plus an injection of Lucentis.
干预措施: Lucentis (Drug)
结局指标
主要结局
Lesion change as measured with fluorescein angiography.
时间窗: Baseline and 12 months
Change in the proportion of the lesion which is active at 12 months.
次要结局
- Number of Lucentis injections(Baseline and 12 months)
- Visual Acuity change(Baseline and 12 months)