NCT00681603已完成不适用
The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization
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
- 13
- 试验地点
- 1
- 主要终点
- Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
研究概览
简要总结
- Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
- Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
- Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
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
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
- •The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
- •Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
- •Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
- •The corneal neovascularization was refractory to other medical treatment
- •The patient had received PKP or other corneal surgeries more than half a year ago and was not in the acute post-operation phase
- •The patient had no active endopthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases
- •The patient signed inform consent to have regular follow up and treatment
排除标准
- •The neovascularization had clinical improvement three months before the first injection
- •The lipid keratopathy had clinical improvement three months before the first injection
- •The patient that suspected to have poor visual outcome or had already been light sense negative
- •Glaucoma patient that had uncontrolled intraocular pressure
- •Poor corneal epithelialization
- •Post-PKP patient that had graft failure or rejection
- •Patient that had systemic disease which was not suitable for bevacizumab use
- •Pregnant patient
研究组 & 干预措施
1
Experimental
13 cases that accepted subconjunctival injection of bevacizumab
干预措施: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg) (Drug)
结局指标
主要结局
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
时间窗: prospective
次要结局
- major side effects(prospective)
研究者
研究点 (1)
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