Emory University, Atlanta, Georgia, USA.
The Emmes Company, LLC, Rockville, Maryland, USA.
Am J Ophthalmol. 2021 Feb;222:185-193. doi: 10.1016/j.ajo.2020.08.030. Epub 2020 Aug 20.
To investigate the relationship between intraretinal macular hemorrhage and visual acuity outcomes in eyes with central retinal vein occlusion or hemiretinal vein occlusion managed with aflibercept, bevacizumab, or observation.
Retrospective analysis of data from 2 randomized clinical trials.
A total of 362 participants were randomized in the Study of Comparative Treatments for Retinal Vein Occlusion 2, and 88 participants randomized to observation in the Standard Care vs Corticosteroid in Retinal Vein Occlusion Study. Participants received monthly intravitreal aflibercept or bevacizumab through month 6 or observation through month 8. The main outcome was visual acuity letter score (VALS).
Reduced area of hemorrhage by month 6 was observed in 70.7% (116 of 164) of aflibercept-treated eyes, 63.8% (104 of 163) of bevacizumab-treated eyes, and 42.2% (27 of 64) of observation eyes by month 8 (P < .01). Relative to eyes with hemorrhage during follow-up, aflibercept-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 8.0 (99% confidence interval [CI]: 1.9, 14.2); bevacizumab-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 3.2 (99% CI: -4.6, 11.0); and observation eyes without hemorrhage at month 8 had a mean VALS improvement of 13.5 (99% CI: 0.4, 26.5). At month 6, the presence of hemorrhage and the change in central subfield thickness (CST) were significantly associated with the change in VALS; however, CST was a more important predictor.
Improvement in hemorrhage during follow-up was associated with visual acuity improvements and predicted visual acuity changes beyond what was explained by CST. These findings suggest that intraretinal macular hemorrhage is an important indicator of disease severity in retinal vein occlusion.
研究在接受阿柏西普、贝伐单抗或观察治疗的中心性视网膜静脉阻塞或半侧视网膜静脉阻塞患者中，视网膜内出血与视力结局的关系。
对 2 项随机临床试验数据的回顾性分析。
在视网膜静脉阻塞 2 期比较治疗研究中，共有 362 名参与者被随机分组，88 名参与者在标准治疗与皮质类固醇治疗视网膜静脉阻塞研究中被随机分组至观察组。参与者在第 1 个月至第 6 个月接受每月 1 次玻璃体腔内注射阿柏西普或贝伐单抗治疗，或在第 1 个月至第 8 个月接受观察组治疗。主要结局是视力字母评分（VALS）。
在第 6 个月，阿柏西普治疗组有 70.7%（116/164）的眼、贝伐单抗治疗组有 63.8%（104/163）的眼和观察组有 42.2%（27/64）的眼观察到出血面积减少（P＜.01）。与随访期间存在出血的眼相比，在第 6 个月无出血的阿柏西普治疗眼的平均 VALS 改善值为 8.0（99%置信区间[CI]：1.9，14.2）；在第 6 个月无出血的贝伐单抗治疗眼的平均 VALS 改善值为 3.2（99%CI：-4.6，11.0）；在第 8 个月无出血的观察组的平均 VALS 改善值为 13.5（99%CI：0.4，26.5）。在第 6 个月时，出血的存在和中心凹下视网膜厚度（CST）的变化与 VALS 的变化显著相关；然而，CST 是一个更重要的预测因素。
在随访期间出血的改善与视力提高相关，并预测了 CST 无法解释的视力变化。这些发现表明，视网膜内出血是视网膜静脉阻塞疾病严重程度的一个重要指标。
