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阿柏西普在渗出性年龄相关性黄斑变性中的初始应用。

Initial utilization of aflibercept in exudative age-related macular degeneration.

作者信息

Cho Hyung, Weber Marissa L, Shah Chirag P, Heier Jeffrey S

机构信息

Ophthalmic Consultants of Boston, Boston, Massachusetts - USA.

出版信息

Eur J Ophthalmol. 2014 Jul-Aug;24(4):576-81. doi: 10.5301/ejo.5000421. Epub 2014 Mar 17.

Abstract

PURPOSE

Intravitreal aflibercept, a fusion protein with high affinity for vascular endothelial growth factor, offers an alternative treatment for exudative age-related macular degeneration. Preclinical studies and early and late phase clinical trials suggest that aflibercept's high binding affinity may impart greater durability of activity and increased efficacy compared to ranibizumab or bevacizumab.

METHODS

A total of 266 eyes of 249 patients with exudative age-related macular degeneration who received aflibercept after treatment with bevacizumab and/or ranibizumab were included in a retrospective review. Mean central subfoveal thickness on spectral-domain optical coherence tomography and mean logarithm of the minimal angle of resolution (logMAR) visual acuity were calculated at 1, 3, 6, and 12 months after the first aflibercept injection. Subgroup analyses were performed in eyes receiving at least 5 bevacizumab and/or ranibizumab injections in the 6 months prior to aflibercept and in eyes receiving at least 10 injections in the 12 months prior to aflibercept.

RESULTS

Eyes received an average of 14.7 (range 1-43) ranibizumab and/or bevacizumab treatments prior to initiation of aflibercept therapy. The mean central subfoveal thickness decreased from 300 to 275 µm at 1 month (p<0.001) and was maintained at 6 months. Mean logMAR visual acuity improved from 0.60 (Snellen equivalent 20/80) to 0.54 (20/70, p = 0.01) at 1 month and was stable at 0.55 at 6 months (Snellen equivalent 20/70, p = 0.11, n = 251). In 82 eyes receiving at least 5 injections in the 6 months prior to aflibercept treatment (average of 18.1 injections total), the central subfoveal thickness improved from 296 to 279 µm at 1 month (p<0.0001) and was maintained at 6 months (p<0.0001). Visual acuity did not change (0.48 [20/61] at 1 month compared to baseline, 0.49 [20/62], p = 0.634, and at 6 months 0.51 [20/65], p = 0.601). In 50 eyes receiving at least 10 injections in the 12 months prior to aflibercept treatment (average of 21.8 injections total), the mean central subfoveal thickness decreased by 17 µm at 1 month (p = 0.0007) and was maintained at 6 months (p = 0.013). Again, visual acuity did not change (0.46 [20/56] at 1 month, baseline 0.44 [20/56], p = 0.547, and 0.50 [20/63] at 6 months, p = 0.2445).

CONCLUSIONS

Aflibercept is a valuable treatment alternative in patients previously treated with bevacizumab and/or ranibizumab injections. Stability of visual acuity and anatomic improvement on spectral-domain optical coherence tomography were observed after initiation of aflibercept treatment in those preciously treated with ranibizumab and/or bevacizumab injections every 4-6 weeks.

摘要

目的

阿柏西普是一种对血管内皮生长因子具有高亲和力的融合蛋白,为渗出性年龄相关性黄斑变性提供了一种替代治疗方法。临床前研究以及早期和晚期临床试验表明,与雷珠单抗或贝伐单抗相比,阿柏西普的高结合亲和力可能使其活性更持久且疗效增加。

方法

对249例接受过贝伐单抗和/或雷珠单抗治疗后又接受阿柏西普治疗的渗出性年龄相关性黄斑变性患者的266只眼进行回顾性研究。在首次注射阿柏西普后的1、3、6和12个月,计算光谱域光学相干断层扫描上的平均中心凹下厚度以及最小分辨角的平均对数视力(logMAR)。对在阿柏西普治疗前6个月内接受至少5次贝伐单抗和/或雷珠单抗注射的眼以及在阿柏西普治疗前12个月内接受至少10次注射的眼进行亚组分析。

结果

在开始阿柏西普治疗前,这些眼平均接受了14.7次(范围1 - 43次)雷珠单抗和/或贝伐单抗治疗。1个月时,平均中心凹下厚度从300 µm降至275 µm(p<0.001),并在6个月时维持该水平。平均logMAR视力在1个月时从0.60(Snellen视力相当于20/80)提高到0.54(20/70,p = 0.01),在6个月时稳定在0.55(Snellen视力相当于20/70,p = 0.11,n = 251)。在阿柏西普治疗前6个月内接受至少5次注射的82只眼(总共平均18.1次注射)中,中心凹下厚度在1个月时从296 µm改善至279 µm(p<0.0001),并在6个月时维持该改善(p<0.0001)。视力未改变(1个月时为0.48 [20/61],与基线相比,0.49 [20/62],p = 0.634,6个月时为0.51 [20/

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