The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
Genentech, Inc., South San Francisco, California.
Ophthalmology. 2015 Jul;122(7):1395-401. doi: 10.1016/j.ophtha.2015.02.036. Epub 2015 Apr 11.
To investigate baseline predictors of month 24 best-corrected visual acuity (BCVA) and central foveal thickness (CFT) in patients with diabetic macular edema (DME) treated monthly with ranibizumab or sham.
Post hoc analysis of DME patients in 2 identical phase 3 studies.
Patients randomized to ranibizumab (n = 502) or sham (n = 257).
Multivariate regression on predictors with P < 0.20 in univariate logistic regression using backward selection to retain predictors with P < 0.05.
Patient characteristics correlating with month 24 BCVA in Early Treatment Diabetic Retinopathy Study letter score ≥70 (20/40) or ≤50 (20/100), gain or loss from baseline BCVA of ≥15, or CFT ≤250 μm.
Baseline predictors of BCVA ≥20/40 in ranibizumab-treated patients were good BCVA, submacular fluid, no cardiovascular disease, no scatter photocoagulation, and male gender, whereas in sham-treated patients, they were mild increase in CFT, presence of hard exudates in center subfield, and absence of renal disease. Predictors of improvement in BCVA letter score ≥15 in ranibizumab-treated patients were poor BCVA, submacular fluid, young age, and short diabetes duration, and those in sham-treated patients were poor BCVA, young age, and mild increase in CFT. Predictors of resolution of edema (CFT ≤250 μm) in ranibizumab-treated patients were mild foveal thickening and prominent subfoveal fluid, and those in sham-treated patients were poor BCVA, mild foveal thickening, and statin usage. Month 24 BCVA ≤20/100 was predicted by poor baseline BCVA in ranibizumab-treated patients, and by poor baseline BCVA, large intraretinal cystoid spaces, renal disease, and absence of hypercholesterolemia in sham-treated patients. Loss of BCVA ≥15 letters was predicted in sham-treated patients by submacular fluid, intraretinal cystoid spaces, and renal disease.
Patients with DME and submacular fluid, intraretinal cysts, severe thickening, or renal disease respond poorly when untreated and respond well to ranibizumab treatment. Elimination of submacular fluid, intraretinal cysts, and severe thickening are important goals of DME treatment, and in patients with renal disease, treatment should be very aggressive, with a goal of eliminating all macular fluid.
探究接受每月雷珠单抗或假注射治疗的糖尿病黄斑水肿（DME）患者在第 24 个月最佳矫正视力（BCVA）和中心凹视网膜厚度（CFT）的基线预测因素。
两项相同的 3 期研究中的 DME 患者的事后分析。
接受雷珠单抗（n = 502）或假注射（n = 257）治疗的患者。
使用向后选择保留 P < 0.05 的预测因素，对单变量逻辑回归中 P < 0.20 的预测因素进行多变量回归。
与第 24 个月的 BCVA 相关的患者特征，采用早期糖尿病视网膜病变研究字母评分≥70（20/40）或≤50（20/100）、基线 BCVA 增益或损失≥15、或 CFT ≤250 μm。
雷珠单抗治疗患者 BCVA≥20/40 的基线预测因素是较好的 BCVA、黄斑下积液、无心血管疾病、无散在光凝和男性，而在假治疗患者中，是 CFT 的轻度增加、中心凹下区域存在硬性渗出物以及无肾脏疾病。雷珠单抗治疗患者 BCVA 字母评分提高≥15 的预测因素是较差的 BCVA、黄斑下积液、年龄较小和糖尿病病程较短，而在假治疗患者中，是较差的 BCVA、年龄较小和 CFT 的轻度增加。雷珠单抗治疗患者水肿（CFT≤250μm）消退的预测因素是轻度的中心凹增厚和明显的黄斑下积液，而在假治疗患者中，是较差的 BCVA、轻度的中心凹增厚和他汀类药物的使用。雷珠单抗治疗患者的第 24 个月 BCVA≤20/100 由基线较差的 BCVA 预测，而假治疗患者的第 24 个月 BCVA≤20/100 则由基线较差的 BCVA、较大的视网膜内囊样水肿、肾脏疾病和无高胆固醇血症预测。假治疗患者的 BCVA 损失≥15 个字母由黄斑下积液、视网膜内囊样水肿和肾脏疾病预测。
未治疗的 DME 伴黄斑下积液、视网膜内囊肿、严重增厚或肾脏疾病的患者反应较差，而对雷珠单抗治疗反应良好。消除黄斑下积液、视网膜内囊肿和严重增厚是 DME 治疗的重要目标，对于患有肾脏疾病的患者，治疗应非常积极，目标是消除所有黄斑积液。
