Nguyen Quan Dong, Shah Syed Mahmood, Hafiz Gulnar, Do Diana V, Haller Julia A, Pili Roberto, Zimmer-Galler Ingrid E, Janjua Kashif, Symons R C Andrew, Campochiaro Peter A
Department of Ophthalmology, The Johns Hopkins University School of Medicine, 600 North Wolfe Street, Baltimore, MD 21287, USA.
Am J Ophthalmol. 2008 Feb;145(2):257-266. doi: 10.1016/j.ajo.2007.09.025. Epub 2007 Dec 11.
To investigate the safety, tolerability, and bioactivity of intravenous infusions of bevacizumab in patients with choroidal neovascularization (CNV) attributable to causes other than age-related macular degeneration.
Nonrandomized clinical trial.
Ten patients with CNV received infusions of 5 mg/kg of bevacizumab. The primary efficacy outcome measure was change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study letters read at 4 meters) at 24 weeks and secondary measures were changes from baseline in excess foveal thickness (center subfield thickness), area of fluorescein leakage, and area of CNV.
Infusions were well tolerated and there were no ocular or systemic adverse events. At baseline, median VA was 25.5 letters read at 4 meters (20/80) and median foveal thickness was 346 mum. At the primary endpoint (24 weeks), median VA was 48.5 letters (20/32), representing four lines of improvement from baseline (P = .005), median foveal thickness was 248 mum representing a 72% reduction in excess foveal thickness (P = .007). Four of nine patients had complete elimination of fluorescein leakage, three had near complete elimination (reductions of 91%, 88%, and 87%), two had modest reductions, and one had no reduction. All patients except one showed a reduction in area of CNV with a median reduction of 43%.
Despite the small number of patients studied, the marked improvement in VA accompanied by prominent reductions in foveal thickness, fluorescein leakage, and area of CNV suggest a beneficial effect. It may be worthwhile to consider further evaluation of systemic bevacizumab in young patients with CNV.
研究静脉输注贝伐单抗对非年龄相关性黄斑变性所致脉络膜新生血管(CNV)患者的安全性、耐受性和生物活性。
非随机临床试验。
10例CNV患者接受5mg/kg贝伐单抗输注。主要疗效指标为24周时视力(VA;早期糖尿病性视网膜病变研究中在4米处读出的字母数)的变化,次要指标为中心凹厚度(中心子区域厚度)、荧光素渗漏面积和CNV面积相对于基线的变化。
输注耐受性良好,未出现眼部或全身不良事件。基线时,平均视力为在4米处读出25.5个字母(20/80),平均中心凹厚度为346μm。在主要终点(24周)时,平均视力为48.5个字母(20/32),较基线提高了4行(P = 0.005),平均中心凹厚度为248μm,中心凹厚度超标减少了72%(P = 0.007)。9例患者中有4例荧光素渗漏完全消除,3例接近完全消除(减少了91%、88%和87%),2例有适度减少,1例无减少。除1例患者外,所有患者的CNV面积均减少,平均减少43%。
尽管研究的患者数量较少,但视力的显著改善伴随着中心凹厚度、荧光素渗漏和CNV面积的显著减少,提示有有益作用。对于年轻的CNV患者,考虑进一步评估全身应用贝伐单抗可能是值得的。