Pilot study to evaLuate the role of high-dose rAnibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with perSistent/recurrenT macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study)
Pilot study to evaLuate the role of high-dose rAnibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with perSistent/recurrenT macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study)
复制标题
评估高剂量 rAnibizumab 2.0 mg 在治疗玻璃体内抗 VEGF 治疗后 30 天以内持续/复发性黄斑积液患者的新生血管性年龄相关性黄斑变性中的作用的初步研究（最后研究）
作者：
A. Fung;N. Kumar;Sushma K Vance;J. Slakter;J. Klancnik;R. Spaide;K. B. Freund;K. B. Freund;K. B. Freund
目的确定玻璃体内注射雷珠单抗2.0 mg对顽固性新生血管性年龄相关性黄斑变性（AMD）患者的疗效。方法这项单盲、随机、前瞻性、初步研究招募了中心凹下新生血管性AMD患者。在至少6个月玻璃体内注射雷珠单抗或贝伐单抗后，所有研究眼睛在光谱域光学相干断层扫描（SD-OCT）上具有持续性视网膜下（SRF）或视网膜内液体（IRF）<30天。患者以2：1的比例随机接受雷珠单抗2.0或0.5 mg。在间隔4周的三次负荷治疗后，两组均使用眼跟踪SD-OCT指导的“治疗和扩展”方案治疗至第12个月。主要观察指标为术后6个月最佳矫正视力（BCVA）的平均变化。结果9例（9眼）患者（平均年龄82.0±5.8岁）入组。7只眼接受雷珠单抗2.0 mg，2只眼接受0.5 mg。由于入组的患者数量较少，因此无法对两种剂量进行统计学比较。第6个月时，2.0和0.5 mg组BCVA的平均改善分别为+6.1 3. 7（W=0，P<0.001）ETDRS字母和+2.0 ETDRS字母。在2.0 mg组中，与基线相比，6个月时中央凹厚度、SRF和最大色素上皮脱离高度在统计学上显著下降。没有不良事件的报道，在任何group.ConclusionRanibizumab 2.0毫克有可能维持或改善BCVA持续或复发的SRF或IRF继发于新生血管性AMD的一些患者，尽管先前每月玻璃体内抗血管内皮生长因子治疗的标准剂量。
PurposeTo determine the efficacy of intravitreal ranibizumab 2.0 mg in patients with recalcitrant neovascular age-related macular degeneration (AMD).MethodsThis single-masked, randomized, prospective, pilot study enrolled patients with subfoveal neovascular AMD. All study eyes had persistent subretinal (SRF) or intraretinal fluid (IRF) on spectral-domain optical coherence tomography (SD-OCT) <30 days following at least 6 monthly intravitreal injections of ranibizumab or bevacizumab. Patients were randomized 2 : 1 to receive either ranibizumab 2.0 or 0.5 mg. Following three-loading treatments 4-weeks apart, both groups were treated using a ‘treat and extend’ regimen guided by eye-tracked SD-OCT through month 12. The primary end point was the mean change in best-corrected visual acuity (BCVA) at month 6.ResultsNine eyes of 9 patients (mean age±SD, 82.0±5.8 years) were enrolled. Seven eyes received ranibizumab 2.0 mg and two eyes received 0.5 mg. Owing to the small number of patients enrolled, no statistical comparison could be made between the two dosages. At month 6, the mean improvement in BCVA was +6.1±3.7 (W=0, P<0.001) ETDRS letters and +2.0 ETDRS letters in the 2.0 and 0.5 mg groups, respectively. In the 2.0 mg group, there was a statistically significant decline in central foveal thickness, SRF and maximum pigment epithelial detachment height at 6 months compared with baseline. No adverse events were reported in either group.ConclusionRanibizumab 2.0 mg has the potential to maintain or improve BCVA in some patients with persistent or recurrent SRF or IRF secondary to neovascular AMD despite prior monthly intravitreal anti-vascular endothelial growth factor therapy with the standard dose.
DOI：
10.1056/nejmoa1102673
发表时间：
2011-05-19
期刊：
The New England journal of medicine
影响因子：
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作者：
CATT Research Group;Martin DF;Maguire MG;Ying GS;Grunwald JE;Fine SL;Jaffe GJ
通讯作者：
Jaffe GJ