University College of London Institute of Ophthalmology, London, United Kingdom.
National Institute for Health Research Moorfields Biomedical Research Centre, London, United Kingdom.
JAMA Ophthalmol. 2022 Feb 1;140(2):143-150. doi: 10.1001/jamaophthalmol.2021.5619.
It is unclear how visual outcomes vary between patterns of macular edema (ME) resolution in eyes with central retinal vein occlusion (CRVO).
To assess best-corrected visual acuity (BCVA) outcomes at 100 weeks based on macular fluid resolution patterns by 52 and 100 weeks among patients receiving anti-vascular endothelial growth factor therapy for CRVO-related ME.
DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of the prospective, 3-arm, double-masked, randomized noninferiority trial Lucentis, Eylea, Avastin in Vein Occlusion (LEAVO), which evaluated intravitreal aflibercept (2.0 mg/0.05 mL), bevacizumab (1.25-mg/0.05 mL), or ranibizumab (0.5 mg/0.05 mL) over 100 weeks in adult patients (18 years and older) with CRVO-related ME with BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 19 to 78 in the study eye (approximate Snellen equivalent, 20/400 to 20/32, respectively) from December 2014 to December 2016 at 44 UK National Health Service ophthalmology departments. A total of 140 of 154 eyes were randomized to aflibercept, 144 of 154 randomized to bevacizumab, and 141 of 155 randomized to ranibizumab. Data were analyzed from January 2019 to March 2019.
Persistent ME included eyes with central subfield thickness (CST) 320 μm or greater, and persistently dry macula (no ME) included eyes with CST less than 320 μm at 52 and 100 weeks. Recurrent ME included eyes that did not meet the criteria for persistently dry or wet. If CST was missing, the closest intervening visit was carried forward.
Adjusted mean BCVA at 100 weeks.
The mean (SD) age of the 425 included participants was 69.2 (12.7) years, and 243 participants (57.2%) were men. A total of 425 eyes from 425 participants were included. By 100 weeks, 117 eyes (28.5%) were persistently dry, 44 (10.7%) were persistently wet (with ME), and 250 (60.8%) had recurrent ME. Persistent ME at 100 weeks was associated with worse VA compared with dry macula (adjusted difference, -10.98 ETDRS letters; 95% CI, -16.19 to -5.76; P < .001) and recurrent ME (adjusted difference, -5.39 letters; 95% CI, -10.15 to -0.64; P = .03). By 52 weeks, individuals with persistent ME also had poorer 100-week BCVA compared with individuals with dry macula (adjusted difference, -7.39; 95% CI, -11.72 to -3.05; P < .001) and recurrent ME (adjusted difference, -3.92; 95% CI, -8.05 to 0.20; P = .06). By 100 weeks, more eyes treated with bevacizumab had persistently wet macula than those treated with aflibercept (26 of 140 [18.6%] vs 7 of 134 [5.2%]; difference, 13.3%; 95% CI, 5.9 to 20.8; P < .001) or ranibizumab (11 of 137 [8%]; difference, 10.5%; 95% CI, 2.7 to 18.4; P = .01).
These findings suggest that attempts should be made to maintain persistently fluid-free macula for optimal visual acuity outcomes.
尚不清楚中央性视网膜静脉阻塞(CRVO)患者中,黄斑水肿(ME)消退的模式如何影响视力结果。
评估接受抗血管内皮生长因子治疗的 CRVO 相关 ME 患者,在第 52 周和第 100 周时,根据黄斑区液体消退模式,评估最佳矫正视力(BCVA)的结果。
设计、地点和参与者:回顾性分析前瞻性、3 臂、双盲、随机非劣效性试验 Lucentis、Eylea、Avastin in Vein Occlusion(LEAVO)的结果,该试验评估了玻璃体内阿柏西普(2.0 mg/0.05 mL)、贝伐单抗(1.25-mg/0.05 mL)或雷珠单抗(0.5 mg/0.05 mL)在 2014 年 12 月至 2016 年 12 月期间,154 例年龄在 18 岁及以上的 CRVO 相关 ME 患者中,使用 100 周,研究眼的最佳矫正视力 ETDRS 字母评分(约 Snellen 等效视力,分别为 20/400 至 20/32)。共有 140 只眼随机分配至阿柏西普组,144 只眼随机分配至贝伐单抗组,141 只眼随机分配至雷珠单抗组。数据分析于 2019 年 1 月至 3 月进行。
持续性 ME 包括中央区视网膜厚度(CST)≥320 μm的患者,干性黄斑(无 ME)包括 CST 在第 52 周和第 100 周时小于 320 μm的患者。复发性 ME 包括不符合持续干性或湿性标准的患者。如果 CST 缺失,则采用最近的随访数据进行替代。
100 周时的平均调整 BCVA。
425 名纳入患者的平均(SD)年龄为 69.2(12.7)岁,243 名(57.2%)患者为男性。425 名参与者的 425 只眼纳入研究。至 100 周时,117 只眼(28.5%)持续干性黄斑,44 只眼(10.7%)持续湿性黄斑(有 ME),250 只眼(60.8%)出现复发性 ME。100 周时持续性 ME 与干性黄斑(校正差异,-10.98 ETDRS 字母;95%CI,-16.19 至-5.76;P<0.001)和复发性 ME(校正差异,-5.39 个字母;95%CI,-10.15 至-0.64;P=0.03)相比,VA 更差。至第 52 周时,与干性黄斑(校正差异,-7.39;95%CI,-11.72 至-3.05;P<0.001)和复发性 ME(校正差异,-3.92;95%CI,-8.05 至 0.20;P=0.06)相比,持续性 ME 患者的 100 周 BCVA 也更差。至 100 周时,与接受阿柏西普治疗的患者相比,接受贝伐单抗治疗的患者中持续湿性黄斑的发生率更高(140 例中的 26 例[18.6%] vs 134 例中的 7 例[5.2%];差异,13.3%;95%CI,5.9 至 20.8;P<0.001)或雷珠单抗(137 例中的 11 例[8%];差异,10.5%;95%CI,2.7 至 18.4;P=0.01)。
这些发现表明,为了获得最佳视力结果,应努力保持黄斑区持续无液。