METHODS: This is a single-center retrospective comparative study of treatment-naïve patients who received intravitreal ranibizumab or aflibercept administration for DME for at least 12 months on an as needed regimen following three-monthly loading doses. The primary outcomes of the study were the mean change in best-corrected visual acuity (BCVA), central macular thickness (CMT), and central macular volume (CMV). Factors to potentially affect these parameters were also analyzed.
RESULTS: A total of 100 eyes (66 patients) were included in the study. Fifty two eyes received ranibizumab and 48 eyes in aflibercept injections. At the end of follow-up, the improvement in mean BCVA was similar in both groups (p = 0.38). While the decrease in mean CMT at the 4th-month visit was significantly higher in the aflibercept-treated group than in the ranibizumab-treated group (p = 0.02), there was no difference between the two groups at the end of the 1-year follow-up (p = 0.25). There was no significant difference between the two groups in terms of change in mean CMV during the follow-up (p = 0.26, p = 0.27 at 4 and 12 months, respectively). The mean number of injections were also similar between groups (4.5 ± 1 vs. 4.6 ± 1.1 respectively, p = 0.63).
CONCLUSIONS: In a real-world setting, ranibizumab and aflibercept were both found to be effective in the first-line treatment of DME. Patients with DME who received fewer injections in the real-world could achieve visual and anatomical results comparable to randomized controlled trials participants.
方法:这是一项单中心回顾性比较研究,针对未治疗的患者,这些患者在三个月的负荷剂量后,根据需要接受玻璃体内雷珠单抗或阿柏西普治疗DME至少12个月。研究的主要结果是最佳矫正视力(BCVA)的平均变化,黄斑中心厚度(CMT),和中央黄斑体积(CMV)。还分析了可能影响这些参数的因素。
结果:本研究共纳入100只眼(66例患者)。52只眼接受雷珠单抗治疗,48只眼接受阿柏西普注射治疗。在后续行动结束时,两组平均BCVA改善相似(p=0.38).尽管阿柏西普治疗组第4个月就诊时平均CMT的下降明显高于雷珠单抗治疗组(p=0.02),在1年随访结束时,两组间无差异(p=0.25).两组在随访期间平均CMV的变化没有显着差异(在4和12个月时p=0.26,p=0.27,分别)。两组之间的平均注射次数也相似(4.5±1vs.4.6±1.1p=0.63)。
结论:在现实世界中,发现雷珠单抗和阿柏西普在DME的一线治疗中均有效.在现实世界中接受较少注射的DME患者可以获得与随机对照试验参与者相当的视觉和解剖学结果。