Abstract：
OBJECTIVE: To compare the visual and anatomic outcomes of intravitreal ranibizumab versus aflibercept in patients with diabetic macular edema (DME) in a real-world study.
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.
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.
摘要：
目的：在真实世界研究中比较玻璃体内注射雷珠单抗与阿柏西普在糖尿病性黄斑水肿（DME）患者中的视觉和解剖结果。
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。
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。
