Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California 90033, USA.
Retina. 2010 Oct;30(9):1390-9. doi: 10.1097/IAE.0b013e3181e44599.
To compare lesion anatomical responses to ranibizumab versus verteporfin photodynamic therapy (PDT) in the ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization [CNV] in Age-Related Macular Degeneration) study.
In this 2-year, Phase III, randomized, multicenter, double-masked trial, 423 patients received ranibizumab (0.3 or 0.5 mg) monthly + sham PDT or PDT + monthly sham injection. Photodynamic therapy (or sham PDT) was administered at Day 0 and then quarterly as needed. A central reading center assessed fundus photography and fluorescein angiography images. A subset (n = 61) had optical coherence tomography assessments. Main outcome measures included mean change from baseline at Months 12 and 24 for area of classic CNV and total area of leakage from CNV.
At Months 12 and 24, ranibizumab was superior to PDT (P < 0.0001) for mean changes from baseline in total area of lesion, CNV area, and total area CNV leakage. Month 12 optical coherence tomographies showed greater center point thickness decrease from baseline with ranibizumab than with PDT (P = 0.0003). Ranibizumab benefits over PDT were evident by 3 months (fluorescein angiography) and 7 days (optical coherence tomography).
Differences between the PDT and the ranibizumab groups in lesion anatomical outcomes were early, sustained, and favored ranibizumab.
比较抗 VEGF 抗体(雷珠单抗)与维替泊芬光动力疗法(PDT)治疗年龄相关性黄斑变性中典型脉络膜新生血管(CNV)为主的病变解剖学反应。
这是一项为期 2 年的 III 期、随机、多中心、双盲试验,共纳入 423 例患者,接受每月 0.3 或 0.5mg 雷珠单抗+假 PDT 或 PDT+每月假注射。PDT(或假 PDT)在第 0 天给予,然后根据需要每季度给予一次。一个中央阅读中心评估眼底照相和荧光素血管造影图像。一部分(n=61)接受光学相干断层扫描评估。主要观察指标包括基线后 12 个月和 24 个月时典型 CNV 面积和 CNV 渗漏总面积的平均变化。
在基线后 12 个月和 24 个月,雷珠单抗在病变总面积、CNV 面积和 CNV 渗漏总面积的平均变化方面优于 PDT(P<0.0001)。12 个月的光学相干断层扫描显示雷珠单抗比 PDT 有更大的中心厚度从基线下降(P=0.0003)。雷珠单抗与 PDT 相比,在第 3 个月(荧光素血管造影)和第 7 天(光学相干断层扫描)时,疗效就更为显著。
病变解剖学结局中 PDT 组和雷珠单抗组之间的差异是早期、持续的,并且有利于雷珠单抗。