Topical/Subconjunctival Injection of Bevacizumab(Avastin) for the Treatment of Corneal Neovascularization
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Regression of corneal neovascularization
研究概览
简要总结
The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.
详细描述
The compassionate off-label use of bevacizumab as well as the potential risks, benefits, and adverse effects of this medication are discussed extensively with each patient. To further minimize systemic absorption, silicone punctual plugs are placed in the lower eyelids. One group of patients apply topical bevacizumab, 1.0%(10mg/ml), 4 times of day. The other group of patients received subconjunctival injection of bevacizumab(2.5mg/0.1ml) once. The patients are examined at 1day, 1week, 2weeks, 3weeks, and 1month, then monthly till the corneal neovascularization are gone or reduced to some degrees. Best-corrected visual acuity, slip-lamp examination, tonometry, external photography, pachymetry, specular microscopy (if possible), and systemic blood pressure are completed at all visits.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
- •Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/
- •Post-PSP or ocular surface reconstruction 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 mort than half a year ago and was not in the acute post-operation phase.
- •The patient had no active endophthalmitis, 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.
- •Patient that had systemic disease which was not suitable for bevacizumab use.
- •Pregnant patient.
研究组 & 干预措施
Bevacizumab
Arm type to experimental based on single group assignment. Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized monoclonal antibody that recognises and blocks vascular endothelial growth factor (VEGF).VEGF is a chemical signal that stimulates the growth of new blood vessels.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Regression of corneal neovascularization
时间窗: 6 months
次要结局
- visual acuity, lipid keratopathy, side effect(6 months)