NCT01288404已完成不适用
A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Severity of impending recurrent pterygium
研究概览
简要总结
Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.
详细描述
- Impending recurrent pterygium
- Anti-VEGF therapy
- Bevacizumab
- Subconjunctival injection
- Suppress neovascularization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
- •Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
- •No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
- •No other ocular surface pathologies or coexisting ocular diseases.
- •No other ocular surgeries within the previous 6 months.
- •No history of allergy to the medications used in this study.
- •Good compliance with the study regimen and availability for the duration of the entire study period.
排除标准
- •Platelet disorders
- •Hypertension
- •Pregnant or lactating women
研究组 & 干预措施
Bevacizumab group 1
Active Comparator
Bevacizumab 1.25 mg/0.05mL
干预措施: Bevacizumab (Drug)
Control
Placebo Comparator
topical 0.1% fluorometholone eye drops
干预措施: Fluorometholone (Drug)
Bevacizumab group 2
Active Comparator
Bevacizumab 2.5 mg/0.1mL
干预措施: Bevacizumab (Drug)
bevacizumab group 3
Active Comparator
bevacizumab 3.75 mg/0.15mL
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Severity of impending recurrent pterygium
时间窗: 3 months
次要结局
- Visual analog scales(3 months)
- Adverse reactions(3 months)
研究者
研究点 (1)
Loading locations...
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