Moorfields Eye Hospital, 162 City Road, London EC1V 2PD, UK.
Br J Ophthalmol. 2013 Jan;97(1):28-32. doi: 10.1136/bjophthalmol-2012-302137. Epub 2012 Oct 20.
To evaluate the off-label use of subconjunctival bevacizumab for corneal neovascularisation (CoNV).
30 patients with recent-onset CoNV from various causes were randomly assigned into a double-masked, placebo-controlled trial. Each received three 0.1 ml injections containing either 2.5 mg bevacizumab or 0.9% saline at monthly intervals. Dexamethasone 0.1% drops were used four times a day for the first month, when the dose was modified if clinically indicated. The primary outcome was change in area of corneal involvement by CoNV from baseline to 3 months measured using specialised imaging technology.
The mean area of CoNV reduced by -36% (range -92% to +40%) in the 15 eyes that received bevacizumab compared with an increase of 90% (range -58% to +1394%) in eyes that received saline placebo (analysis of covariance (ANCOVA); p=0.007). One outlier in the placebo arm developed corneal graft rejection with aggressive neovascularisation (+1384%), but even when this patient was excluded the mean reduction in CoNV in the placebo group (-3%, range -58% to +40%) was still significantly different from the treatment arm (ANCOVA; p=0.016). Changes in best-corrected visual acuity, central corneal thickness, intraocular pressure and endothelial cell counts were similar between groups. The intervention was well tolerated with no major safety concerns.
Three subconjunctival injections of 2.5 mg bevacizumab are more effective than placebo at inducing the regression of recent-onset CoNV. Further studies are needed to confirm this effect and our data suggest that a sample size of 40 patients per treatment group is required.
评估结膜下注射贝伐单抗治疗角膜新生血管(CoNV)的适应证外使用。
30 例不同病因引起的近期 CoNV 患者随机分为双盲、安慰剂对照试验。每组患者每月接受 3 次 0.1ml 注射,分别含有 2.5mg 贝伐单抗或 0.9%生理盐水。在前 1 个月,每天滴用 0.1%地塞米松 4 次,如果临床需要,可调整剂量。主要结局是使用专门的成像技术测量从基线到 3 个月时 CoNV 角膜受累面积的变化。
与接受生理盐水安慰剂的 15 只眼相比,接受贝伐单抗治疗的 15 只眼 CoNV 面积平均减少了 -36%(范围为 -92%至 +40%)(协方差分析(ANCOVA);p=0.007)。安慰剂组的 1 个离群值发生了角膜移植排斥反应,伴有侵袭性新生血管形成(+1384%),但即使排除该患者,安慰剂组 CoNV 的平均减少(-3%,范围为 -58%至 +40%)仍与治疗组有显著差异(ANCOVA;p=0.016)。两组间最佳矫正视力、中央角膜厚度、眼内压和内皮细胞计数的变化相似。干预措施耐受性良好,无重大安全问题。
结膜下注射 2.5mg 贝伐单抗 3 次比安慰剂更能有效诱导近期 CoNV 消退。需要进一步研究来证实这一效果,我们的数据表明,每组需要 40 例患者的样本量。