The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.
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
- Safety
研究概览
简要总结
Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.
详细描述
Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.
Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.
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
- 是
入选标准
- •Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.
排除标准
- •Pregnancy
- •History of CVA
- •Monocular patients
研究组 & 干预措施
Ranibizumab treatment
Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Safety
时间窗: Within the first 30 days after injection
The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.
次要结局
- Regression of pterygium(Within 30 days after drug injection)
研究者
Linda Rose
Principal Investigator
University of New Mexico