Medical College of Wisconsin, Department of Ophthalmology and Visual Sciences, Milwaukee, Wisconsin.
Genentech, Inc., South San Francisco, California.
Ophthalmology. 2019 Dec;126(12):1695-1702. doi: 10.1016/j.ophtha.2019.07.018. Epub 2019 Jul 23.
To investigate characteristics associated with visual and anatomic outcomes in branch and central retinal vein occlusion (BRVO and CRVO) patients treated with ranibizumab.
Post hoc analysis of patients with BRVO and CRVO from 2 multicenter clinical trials who completed month 12 of the HORIZON extension trial.
205 patients with BRVO and 181 patients with CRVO who completed month 12 of the extension trial.
With the use of logistic regression, covariates with a P value < 0.20 from univariate analysis were included in multivariate models to identify independent factors associated with a given outcome (at P < 0.05), with preset variables of disease duration and original treatment assignment.
Best-corrected visual acuity (BCVA) ≥20/40 (≥70 letters), gain ≥15 letters, and central subfield thickness (CST) ≤250 μm at HORIZON month 12.
In patients with BRVO, good baseline BCVA (odds ratio [OR], 1.53; 95% confidence interval [CI], 1.30-1.79), male sex (OR, 2.48; 95% CI, 1.20-5.13), and normal hematocrit (low vs. normal, OR, 0.26; 95% CI, 0.12-0.59) predicted BCVA ≥20/40; high central foveal thickness (OR, 1.03; 95% CI, 1.01-1.04) and normal hematocrit (low vs. normal, OR, 0.31; 95% CI, 0.15-0.66) predicted BCVA improvement ≥15 letters; and extensive baseline subretinal fluid modestly predicted CST ≤250 μm (OR, 1.08; 95% CI, 1.00-1.16). In patients with CRVO, good baseline BCVA (OR, 1.59; 95% CI, 1.35-1.89), never smoking (OR, 2.80; 95% CI, 1.27-6.17), and young age (OR, 0.58; 95% CI, 0.41-0.82) predicted BCVA ≥20/40; never smoking (OR, 2.13; 95% CI, 1.03-4.39), young age (OR, 0.41; 95% CI, 0.28-0.59), poor baseline BCVA (OR, 0.82; 95% CI, 0.73-0.93), hypertension (OR, 4.47; 95% CI, 1.70-11.75), and low diastolic ocular perfusion pressure (OPP) throughout the study (OR, 0.39; 95% CI, 0.21-0.72) predicted BCVA improvement ≥15 letters; and young age (OR, 0.65; 95% CI, 0.47-0.90), lower mean hematocrit (low vs. normal, OR, 2.81; 95% CI, 1.06-7.49), high systolic OPP throughout the study (OR, 1.61; 95% CI, 1.14-2.27), large areas of central hemorrhage (OR, 1.44; 95% CI, 1.04-2.00), and no subretinal fluid (OR, 2.15; 95% CI, 1.06-4.40) predicted CST ≤250 μm.
There are substantial differences in good outcome factors in CRVO versus BRVO, suggesting differences in pathophysiology. Young age, never smoking, hemodilution, and hypertension/high systolic perfusion pressure are more beneficial in CRVO, suggesting that avoidance of sluggish blood flow and maintenance of perfusion may be particularly important in CRVO.
研究接受雷珠单抗治疗的分支和中央视网膜静脉阻塞(BRVO 和 CRVO)患者的视觉和解剖学结果相关特征。
对 2 项多中心临床试验中完成 HORIZON 扩展试验第 12 个月的 BRVO 和 CRVO 患者进行的事后分析。
205 例 BRVO 患者和 181 例 CRVO 患者完成了扩展试验的第 12 个月。
使用逻辑回归,对单变量分析中 P 值 < 0.20 的协变量进行多元模型分析,以确定与特定结果相关的独立因素(P < 0.05),预设变量为疾病持续时间和原始治疗分配。
HORIZON 第 12 个月时最佳矫正视力(BCVA)≥20/40(≥70 个字母)、提高≥15 个字母和中央视网膜神经纤维层厚度(CST)≤250 μm。
在 BRVO 患者中,良好的基线 BCVA(优势比[OR],1.53;95%置信区间[CI],1.30-1.79)、男性(OR,2.48;95%CI,1.20-5.13)和正常血细胞比容(低值与正常,OR,0.26;95%CI,0.12-0.59)预测 BCVA≥20/40;高中央视网膜神经纤维层厚度(OR,1.03;95%CI,1.01-1.04)和正常血细胞比容(低值与正常,OR,0.31;95%CI,0.15-0.66)预测 BCVA提高≥15 个字母;基线广泛的视网膜下液适度预测 CST≤250 μm(OR,1.08;95%CI,1.00-1.16)。在 CRVO 患者中,良好的基线 BCVA(OR,1.59;95%CI,1.35-1.89)、从不吸烟(OR,2.80;95%CI,1.27-6.17)和年轻(OR,0.58;95%CI,0.41-0.82)预测 BCVA≥20/40;从不吸烟(OR,2.13;95%CI,1.03-4.39)、年轻(OR,0.41;95%CI,0.28-0.59)、基线较差的 BCVA(OR,0.82;95%CI,0.73-0.93)、高血压(OR,4.47;95%CI,1.70-11.75)和整个研究过程中低舒张期眼灌注压(OPP)(OR,0.39;95%CI,0.21-0.72)预测 BCVA 提高≥15 个字母;年轻(OR,0.65;95%CI,0.47-0.90)、较低的平均血细胞比容(低值与正常,OR,2.81;95%CI,1.06-7.49)、整个研究过程中较高的收缩期 OPP(OR,1.61;95%CI,1.14-2.27)、较大的中央出血面积(OR,1.44;95%CI,1.04-2.00)和无视网膜下液(OR,2.15;95%CI,1.06-4.40)预测 CST≤250 μm。
CRVO 与 BRVO 相比,良好结局的因素存在显著差异,提示病理生理学存在差异。年轻、从不吸烟、血液稀释和高血压/高收缩期灌注压在 CRVO 中更有益,提示避免血流缓慢和维持灌注可能在 CRVO 中尤为重要。