PURPOSE Both ranibizumab and aflibercept improved vision and decreased macular thickness in eyes with diabetic macular edema (DME) in clinical trials. This study compared the 12-month treatment outcomes of each drug in routine clinical practice. DESIGN Retrospective analysis of data from the prospectively designed observational Fight Retinal Blindness! registry. PARTICIPANTS Treatment-naive eyes tracked in the registry that initiated treatment with either ranibizumab (0.5 mg) or aflibercept (2 mg) for DME from December 1, 2013, through June 1, 2018. METHODS Visual acuity (VA) was analyzed at 12 months in all eyes (completers, noncompleters, and eyes that switched treatment). MAIN OUTCOME MEASURES The primary outcome was the mean change in VA from baseline to 12 months. RESULTS We identified 383 eyes (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes) of 291 patients. Eyes receiving aflibercept showed a lower mean VA (mean difference, -3.1 letters) and a thicker maculae (mean difference, +26 μm) at baseline than those receiving ranibizumab, which were not significantly different. Patients receiving ranibizumab were older (mean difference, +2.7 years). The adjusted mean difference in VA change and central subfield thickness (CST) reduction were, respectively, +1 letter (1.4 letters for aflibercept vs. 0.4 letter for ranibizumab; P = 0.4) and -30 μm (-85 vs. -55 μm; P < 0.01) in eyes with initial VA of 20/40 or better and +3 letters (10.6 vs. 7.6 letters; P < 0.01) and -46 μm (-148 vs. -102 μm; P < 0.02) in those with VA of 20/50 or worse. Eyes in the aflibercept group received more median injections over 12 months than the ranibizumab group although this difference was not significant (8 vs. 6 injections; P = 0.13). Treatment switches, albeit low, were more frequent from ranibizumab to aflibercept than vice versa. Significantly more eyes in the aflibercept group were lost to follow-up within 12 months (21% vs. 9% ranibizumab; P < 0.01). CONCLUSIONS Both drugs were beneficial for DME. Aflibercept-treated eyes, which had borderline worse vision and thicker maculae at baseline, showed larger CST reductions after 12 months of treatment. Larger VA gains were observed with aflibercept treatment when the initial VA was 20/50 or worse.

中文翻译：

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雷尼珠单抗或阿柏西普治疗糖尿病性黄斑水肿：对抗视网膜盲症一年疗效的比较！注册表。

目的在临床试验中，兰尼单抗和abribercept均可改善患有糖尿病性黄斑水肿（DME）的眼睛的视力并降低黄斑厚度。这项研究比较了常规临床实践中每种药物的12个月治疗结果。设计回顾性分析来自预期设计的观察性对抗视网膜盲症的数据！注册表。参与者从2013年12月1日至2018年6月1日，开始使用雷尼珠单抗（0.5 mg）或abribercept（2 mg）进行DME治疗的注册表中未接受过治疗的眼睛。方法分析了12个月时的视敏度（VA）在所有眼睛中（完成者，未完成者和转换治疗的眼睛）。主要观察指标初步观察指标是从基线到12个月VA的平均变化。结果我们确定了383眼（雷珠单抗，n = 166眼；阿柏西普，n = 217眼）的291名患者。与接受兰尼单抗的患者相比，接受阿柏西普的眼睛在基线时具有较低的平均VA（均值差，-3.1个字母）和较厚的黄斑（均值差，+ 26μm），但无显着差异。接受雷珠单抗的患者年龄较大（平均差异为+2.7岁）。VA变化和中心子域厚度（CST）减小的调整后平均差分别为+1个字母（阿柏西普为1.4个字母，兰尼单抗为0.4个字母； P = 0.4）和-30μm（-85对-55μm） ;初始VA为20/40或更高，+ 3个字母（10.6 vs. 7.6个字母; P <0.01）和-46μm（-148 vs -102μm; P <0.02）的眼睛中的P <0.01） VA为20/50或更差。尽管这种差异并不显着（在8次和6次注射； P = 0.13）之间，但阿柏西普组在12个月内的眼睛接受了比兰尼单抗组更多的中位注射。从兰尼单抗到阿柏西普的治疗切换尽管很低，但反之亦然。在12个月内，阿柏西普组失去了更多的眼睛进行随访（21％vs. 9％雷珠单抗； P <0.01）。结论两种药物均对DME有益。经阿柏西普治疗的眼睛在基线时视力较差，黄斑较厚，治疗12个月后，其CST降低量更大。当初始VA为20/50或更差时，使用aflibercept治疗观察到更大的VA增益。在12个月内，阿柏西普组失去了更多的眼睛进行随访（21％vs. 9％雷珠单抗； P <0.01）。结论两种药物均对DME有益。经阿柏西普治疗的眼睛在基线时视力较差，黄斑较厚，治疗12个月后，其CST降低量更大。当初始VA为20/50或更差时，使用aflibercept治疗观察到更大的VA增益。在12个月内，阿柏西普组失去了更多的眼睛进行随访（21％vs. 9％雷珠单抗； P <0.01）。结论两种药物均对DME有益。经阿柏西普治疗的眼睛在基线时视力较差，黄斑较厚，治疗12个月后，其CST降低量更大。当初始VA为20/50或更差时，用aflibercept治疗观察到较大的VA增高。