Lenk J, Matthé E, Pillunat L E, Sandner D
Augenklinik, Universitätsklinikum Carl Gustav Carus, TU Dresden.
Klin Monbl Augenheilkd. 2016 Mar;232(3):284-9. doi: 10.1055/s-0041-107001. Epub 2015 Nov 12.
Since 2007, the standard treatment for age related macular degeneration has been intravitreal injection of ranibizumab. However, despite continuous treatment, some patients fail to achieve remission or stabilisation of the disease. Since 2012, the recombinant fusion protein aflibercept has been available as an alternative treatment. In this study, we investigated whether patients who appear to be resistant to ranibizumab would benefit from treatment with aflibercept.
This retrospective study covered 83 eyes of 81 patients, for whom treatment switch from ranibizumab to aflibercept was indicated. Inclusion criteria were an age ≥ 50 years and at least 10 ranibizumab injections before a switch to aflibercept. Patients with severely impaired visual acuity were excluded. Primary outcomes were improvement or loss of visual acuity (VA) and evaluation of central macular thickness (CMT) via SD-OCT. Secondary endpoints were percentage of eyes without activity of the choroidal neovascular membrane after aflibercept injections and loss or gain of letters on the visual chart. Statistical analysis was performed using SPSS.
VA was 0.83 ± 0.34 logMAR before the first aflibercept injection, with a slight but not statistically significant improvement up to 0.79 ± 0.33 logMAR after the third aflibercept injection (p = 0.205). On the other hand, there was a clear reduction of CMT in OCT, from 451.4 ± 263.0 to 288.2 ± 128.2 µm (p = 0.0001). Overall, 73 % of eyes exhibited better or stable VA and 27 % of eyes lost VA. Interestingly, eyes with worse initial VA gained greater benefit from the switch to aflibercept (p = 0.001).
A switch to aflibercept may lead to stabilisation of choroidal neovascularisation and thus stabilise the visual acuity for patients who appear to be no longer responsive to treatment with ranibizumab.
自2007年以来，年龄相关性黄斑变性的标准治疗方法一直是玻璃体内注射雷珠单抗。然而，尽管持续治疗，一些患者仍未能实现疾病缓解或病情稳定。自2012年以来，重组融合蛋白阿柏西普已作为一种替代治疗药物上市。在本研究中，我们调查了那些似乎对雷珠单抗耐药的患者是否能从阿柏西普治疗中获益。
这项回顾性研究涵盖了81例患者的83只眼，这些患者需要从雷珠单抗转换为阿柏西普治疗。纳入标准为年龄≥50岁且在转换为阿柏西普治疗前至少接受过10次雷珠单抗注射。视力严重受损的患者被排除。主要结局是视力（VA）的改善或下降以及通过SD-OCT评估中心黄斑厚度（CMT）。次要终点是阿柏西普注射后脉络膜新生血管膜无活性的眼的百分比以及视力表上字母的增减。使用SPSS进行统计分析。
首次注射阿柏西普前VA为0.83±0.34 logMAR，第三次注射阿柏西普后略有改善但无统计学意义，达到0.79±0.33 logMAR（p = 0.205）。另一方面，OCT显示CMT明显降低，从451.4±263.0降至288.2±128.2 µm（p = 0.0001）。总体而言，73%的眼视力改善或稳定，27%的眼视力下降。有趣的是，初始视力较差的眼从转换为阿柏西普治疗中获益更大（p = 0.001）。
转换为阿柏西普治疗可能导致脉络膜新生血管稳定，从而使那些似乎对雷珠单抗治疗不再有反应的患者视力稳定。
