Sydney Institute of Vision Science, Sydney, Australia; Save Sight Institute, The University of Sydney, Sydney, Australia.
Sydney Institute of Vision Science, Sydney, Australia.
Ophthalmology. 2014 Jan;121(1):188-192. doi: 10.1016/j.ophtha.2013.08.035. Epub 2013 Oct 18.
OBJECTIVE: To assess the effectiveness of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) previously resistant to treatment with other anti-vascular endothelial growth factor agents. DESIGN: Prospective, open-label, noncontrolled, registered clinical trial. PARTICIPANTS: Forty-nine patients with treatment-resistant neovascular AMD. INTERVENTION: A dose of 2 mg intravitreal aflibercept was administered as 3 initial loading doses every 4 weeks (week 0, week 4, and week 8), followed by further injections every 8 weeks (weeks 16 and 24) across a 24-week period in total. All patients underwent a complete ophthalmic examination, including measurement of Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure assessment, adverse event monitoring, and spectral-domain optical coherence tomography at every visit. Baseline fluorescein angiography and indocyanine green angiography also were performed. MAIN OUTCOME MEASURES: Outcomes assessed included proportions of patients with a gain or loss of more than 5 ETDRS letters and a decrease or increase in central retinal thickness (CRT) of more than 150 μm at week 24 compared with baseline, change in mean BCVA and CRT between baseline and week 24, and descriptive safety data. RESULTS: The BCVA improved and CRT was reduced significantly at all follow-up visits compared with baseline (P < 0.001), with a mean improvement of 6.9 letters of BCVA and a decrease of 89.4 μm in CRT at week 24. Spacing of injections from every 4 weeks to 8 weeks resulted in an increase of 37.4 μm in CRT (P < 0.001); however, this was not correlated with a significant change in vision. There was 1 (2%) patient who lost more than 5 ETDRS letters, and 27 (55%) patients who gained more than 5 letters. Two (4%) patients had a more than 150 μm increase in CRT at week 24, and 10 (20%) patients showed a decrease in CRT of more than 150 μm. CONCLUSIONS: Intravitreal aflibercept is effective in previously treatment-resistant neovascular AMD. Further follow-up is required to determine whether these improvements can be maintained.
目的：评估玻璃体内注射阿柏西普治疗既往对其他抗血管内皮生长因子药物治疗抵抗的新生血管性年龄相关性黄斑变性（AMD）的疗效。
设计：前瞻性、开放标签、非对照、注册临床试验。
参与者：49 例治疗抵抗性新生血管性 AMD 患者。
干预措施：2 毫克玻璃体内注射阿柏西普，前 3 次作为负荷剂量，每 4 周 1 次（第 0 周、第 4 周和第 8 周），随后每 8 周 1 次（第 16 周和第 24 周），共 24 周。所有患者均接受全面眼科检查，包括测量早期治疗糖尿病视网膜病变研究（ETDRS）最佳矫正视力（BCVA）、眼压评估、不良事件监测和每次就诊时的频域光相干断层扫描。基线时还进行荧光素血管造影和吲哚青绿血管造影。
主要观察指标：评估的结果包括与基线相比，第 24 周时视力增加或减少超过 5 个 ETDRS 字母的患者比例，以及中央视网膜厚度（CRT）减少或增加超过 150 μm的患者比例；与基线相比，第 24 周时平均 BCVA 和 CRT 的变化；以及描述性安全性数据。
结果：与基线相比，所有随访时的 BCVA 均提高，CRT 均降低（P < 0.001），第 24 周时 BCVA 平均提高 6.9 个字母，CRT 降低 89.4 μm。将注射间隔从每 4 周延长至 8 周会使 CRT 增加 37.4 μm（P < 0.001）；然而，这与视力的显著变化无关。有 1 例（2%）患者视力下降超过 5 个 ETDRS 字母，27 例（55%）患者视力提高超过 5 个字母。24 周时，有 2 例（4%）患者 CRT 增加超过 150 μm，10 例（20%）患者 CRT 减少超过 150 μm。
结论：玻璃体内注射阿柏西普对既往治疗抵抗的新生血管性 AMD 有效。需要进一步随访以确定这些改善是否能够维持。
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