High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (allergy, infection, or change in vital signs)
研究概览
简要总结
This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
详细描述
This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 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
With Loading Doses
5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)
干预措施: ranibizumab 2.0 mg (Drug)
Physician Discretion
5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.
干预措施: ranibizumab 2.0 mg (Drug)
结局指标
主要结局
Number of participants with adverse events (allergy, infection, or change in vital signs)
时间窗: Baseline, at day 7, then monthly
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
次要结局
- Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography(Monthly Report at Month 12)
- Number of participants with changes in central foveal thickness(Monthly, Report at Month 12)
- Number of participants with changes in visual acuity(Monthly, Report at Month 12)
- Number of injections each group (arm) has received(Monthly, Report at Month 12)
研究者
Paul T. Finger, MD
Principal Investigator
The New York Eye Cancer Center