Department of Ophthalmology, Gulhane School of Medicine, University of Health Sciences, 06010 Ankara, Türkiye.
Department of Ophthalmology, Ankara Training and Research Hospital, 06230 Ankara, Türkiye.
Medicina (Kaunas). 2023 Jan 30;59(2):263. doi: 10.3390/medicina59020263.
The aim of this study was to compare the outcomes of diabetic macular edema (DME) treated with aflibercept (AFB) or ranibizumab (RNB) only, and after switching from RNB to AFB. This was a retrospective, real-world, multicenter (7 cities) 24 month study. Overall, 212 eyes in the AFB group, 461 in the RNB group, and 141 in the RNB to AFB group were included. The primary endpoints were differences in visual acuity (VA) and central macular thickness (CMT) from baseline to the final visit. The secondary outcomes were the percentage of eyes that achieved ≥10 letters gain and ≥10 letters loss in vision at month 12 and 24, and the percentage of eyes that achieved a thinning of ≥20% in CMT at month 3 and month 6. The results showed that VA did not significantly differ at baseline (AFB: 0.62 ± 0.38, RNB: 0.61 ± 0.36, RNB to AFB: 0.61 ± 0.38), at checkpoints, or at the final visit (AFB: 0.46 ± 0.38, RNB: 0.5 ± 0.37, RNB to AFB: 0.53 ± 0.36) ( > 0.05). Though the mean CMT at baseline was significantly thicker in the RNB to AFB group (479 ± 129.6 μm) when compared to the AFB (450.5 ± 122.6 μm) and RNB (442 ± 116 μm) groups ( < 0.01), similar measurements were obtained after 12 months. The percentages of eyes that gained or lost ≥10 letters in the AFB, RNB, and RNB to AFB groups at year 1 and 2 were similar, as was the percentages of eyes that demonstrated ≥20% CMT thinning at month 3 and 6. Our study showed similar visual improvements in non-switchers (AFB and RNB groups) and switchers (RNB to AFB group) through 2 years follow-up, however, AFB patients required fewer injections, visits, or need for additional treatments.
本研究旨在比较单独使用阿柏西普（AFB）或雷珠单抗（RNB）以及从 RNB 转换为 AFB 治疗糖尿病黄斑水肿（DME）的治疗效果。这是一项回顾性、真实世界、多中心（7 个城市）的 24 个月研究。共有 212 只眼纳入 AFB 组，461 只眼纳入 RNB 组，141 只眼纳入 RNB 转 AFB 组。主要终点是从基线到最终随访时视力（VA）和中央黄斑厚度（CMT）的差异。次要结局是在第 12 个月和第 24 个月时视力提高≥10 个字母和下降≥10 个字母的眼比例，以及 CMT 在第 3 个月和第 6 个月时厚度变薄≥20%的眼比例。结果显示，VA 在基线时（AFB：0.62±0.38，RNB：0.61±0.36，RNB 转 AFB：0.61±0.38）、各检查点和最终随访时均无显著差异（AFB：0.46±0.38，RNB：0.5±0.37，RNB 转 AFB：0.53±0.36）（>0.05）。虽然 RNB 转 AFB 组的基线时平均 CMT 明显更厚（479±129.6μm），与 AFB（450.5±122.6μm）和 RNB（442±116μm）组相比（<0.01），但 12 个月后测量值相似。在 AFB、RNB 和 RNB 转 AFB 组中，第 1 年和第 2 年获得或丧失≥10 个字母的眼比例相似，第 3 个月和第 6 个月 CMT 厚度变薄≥20%的眼比例也相似。我们的研究显示，在 2 年的随访中，非转换者（AFB 和 RNB 组）和转换者（RNB 转 AFB 组）的视力均有相似的改善，但 AFB 患者所需的注射次数、就诊次数或额外治疗的需求较少。
