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治疗抵抗性新生血管性年龄相关性黄斑变性患者转换为阿柏西普治疗的长期疗效。

Long-term outcomes of switching to aflibercept for treatment-resistant neovascular age-related macular degeneration.

机构信息

Sydney Retina Clinic & Day Surgery, Sydney, NSW, Australia.

Sydney Institute of Vision Science, Sydney, NSW, Australia.

出版信息

Acta Ophthalmol. 2019 Aug;97(5):e706-e712. doi: 10.1111/aos.14046. Epub 2019 Feb 11.

Abstract

PURPOSE

To report 4-year outcomes following the switch to aflibercept in treatment-resistant neovascular age-related macular degeneration (nAMD).

METHODS

In this prospective, open-label, non-controlled, clinical trial, 49 patients with treatment-resistant nAMD received 2 mg intravitreal aflibercept as three loading doses every 4 weeks, followed by injections every 8 weeks for the first 48 weeks, then an individualized regimen for a further 36 months, following previous treatment with ranibizumab and/or bevacizumab. Outcome measures included best-corrected visual acuity (BCVA), central retinal thickness (CRT), pigment epithelial detachment (PED) height and geographic atrophy (GA) surface area.

RESULTS

Of the 49 patients who were initially recruited, data from 39 eyes of 39 patients were available at 48-month follow-up. Mean age was 76.7 ± 7.2 years. Over the 48 months, these eyes received a mean of 32.1 ± 5.6 injections. The mean BCVA improved significantly following 12 months of treatment (4.9 ± 9.0 ETDRS letters, p < 0.001); however, this was not maintained and was similar to baseline after 48 months (mean difference -0.4 ± 13.3 letters between baseline and 48 months, p < 0.001). The reduction in CRT from baseline was 170.3 ± 143.3 μm (p < 0.001) with absence of macular fluid in 56% of the 39 eyes at the end of month 48. PED height reduced by a mean 77.5 ± 20.0 μm, and geographic atrophy increased by a mean of 4.1 ± 3.4 mm (p < 0.01) over the 48 months.

CONCLUSION

Aflibercept is an effective alternative therapy for treatment-resistant nAMD. Good anatomical and stable functional responses are achievable with continued therapy. The lack of continued visual improvement may be representative of GA progression, reflecting the progression of late-stage nAMD in these patients.

摘要

目的

报告对治疗抵抗性新生血管性年龄相关性黄斑变性(nAMD)转为使用阿柏西普后的 4 年结果。

方法

在这项前瞻性、开放标签、非对照、临床研究中,49 例治疗抵抗性 nAMD 患者接受了 2mg 玻璃体内注射阿柏西普,每 4 周给予 3 次负荷剂量,随后在前 48 周每 8 周注射一次,之后根据个体化方案再治疗 36 个月,此前这些患者接受了雷珠单抗和/或贝伐单抗治疗。主要观察指标包括最佳矫正视力(BCVA)、中心视网膜厚度(CRT)、色素上皮脱离(PED)高度和地图样萎缩(GA)表面积。

结果

最初招募的 49 例患者中,有 39 例患者的 39 只眼在 48 个月随访时可获得数据。平均年龄为 76.7±7.2 岁。在 48 个月期间,这些眼平均接受了 32.1±5.6 次注射。治疗 12 个月后,BCVA 显著提高(4.9±9.0 ETDRS 字母,p<0.001);然而,这一改善在 48 个月时并未维持,与基线相似(与基线相比,48 个月时平均差值为-0.4±13.3 个字母,p<0.001)。与基线相比,CRT 从基线减少了 170.3±143.3μm(p<0.001),48 个月时 56%的 39 只眼中没有黄斑积液。PED 高度平均降低 77.5±20.0μm,GA 平均增加 4.1±3.4mm(p<0.01)。

结论

阿柏西普是治疗抵抗性 nAMD 的有效替代疗法。持续治疗可获得良好的解剖学和稳定的功能反应。视觉改善的缺乏可能代表 GA 的进展,反映了这些患者晚期 nAMD 的进展。

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