Department of Ophthalmology, Boston University School of Medicine, 85 East Concord Street, 8th floor, Boston, MA, 02118, USA.
Veterans Affairs Boston Healthcare System, Jamaica Plain, Boston, MA, USA.
Graefes Arch Clin Exp Ophthalmol. 2021 Aug;259(8):2203-2212. doi: 10.1007/s00417-021-05108-0. Epub 2021 Feb 10.
To identify risk factors for fellow eye treatment of diabetic retinopathy with Vascular Endothelial Growth Factor (VEGF) injections during the Diabetic Retinopathy Clinical Research Network (DRCR.Net) Protocol T trial METHODS: In this post-hoc analysis of randomized clinical trial data, Cox regression analysis was performed at 52 and 104 weeks to determine risk factors for treatment in 360 fellow eyes. Survival analysis was performed to determine mean time to treatment based upon medication used.
Of 360 fellow eyes, 142 (39.4%) required treatment between weeks 4 and 104. Risk factors predicting a lower likelihood of year 1 treatment included older subject age (Hazard Ratio [HR]=0.98, 95% CI 0.96-0.99; p = 0.02) and higher baseline study eye ETDRS score (HR=0.98, 95% CI 0.97-0.99, p = 0.04). Center-involving DME at baseline in the fellow eye was predictive of a higher treatment need at both 52 (HR=1.89, 95% CI 1.42-2.51, p < 0.0001) and 104 weeks (HR=2.68, 95% CI 1.75-4.11, p < 0.0001). Subjects treated in the study eye with aflibercept (HR=0.574, 95% CI 0.371-0.887, p = 0.013) and ranibizumab (HR=0.58, 95%CI 0.36-0.94, p = 0.03) were less likely to require first year fellow eye injection than subjects treated with bevacizumab although this difference was no longer significant at week 104 (aflibercept HR=0.77, 95% CI 0.52-1.16, p = 0.21; ranibizumab HR=0.66, 95% CI 0.43-1.00, p = 0.05). Mean time to treatment was significantly shorter in the bevacizumab group (bevacizumab 25.83 weeks, aflibercept 38.75 weeks, ranibizumab 34.70 weeks (p=0.012)).
Bilateral treatment with intravitreal anti-VEGF injections was common during the DRCR.net Protocol T. Medication choice may impact the risk of fellow eye treatment.
在糖尿病视网膜病变临床研究网络（DRCR.Net）协议 T 试验中，确定接受血管内皮生长因子（VEGF）注射治疗糖尿病性视网膜病变的对侧眼治疗的危险因素。
在这项随机临床试验数据的事后分析中，在第 52 周和第 104 周进行 Cox 回归分析，以确定 360 只对侧眼中 360 只眼的治疗危险因素。进行生存分析以确定基于使用的药物治疗的平均时间。
在 360 只对侧眼中，有 142 只（39.4%）在第 4 周至第 104 周之间需要治疗。预测第一年治疗可能性较低的危险因素包括年龄较大的患者年龄（风险比[HR]=0.98，95%CI 0.96-0.99；p=0.02）和较高的基线研究眼 ETDRS 评分（HR=0.98，95%CI 0.97-0.99，p=0.04）。对侧眼基线时累及中心的 DME 可预测 52 周（HR=1.89，95%CI 1.42-2.51，p<0.0001）和 104 周（HR=2.68，95%CI 1.75-4.11，p<0.0001）时更高的治疗需求。在研究眼中接受阿柏西普（HR=0.574，95%CI 0.371-0.887，p=0.013）和雷珠单抗（HR=0.58，95%CI 0.36-0.94，p=0.03）治疗的患者比接受贝伐单抗治疗的患者更不可能需要第一年的对侧眼注射，尽管在第 104 周时这种差异不再显著（阿柏西普 HR=0.77，95%CI 0.52-1.16，p=0.21；雷珠单抗 HR=0.66，95%CI 0.43-1.00，p=0.05）。贝伐单抗组的平均治疗时间明显缩短（贝伐单抗 25.83 周，阿柏西普 38.75 周，雷珠单抗 34.70 周（p=0.012））。
在 DRCR.Net 协议 T 期间，双侧接受抗 VEGF 眼内注射治疗很常见。药物选择可能会影响对侧眼治疗的风险。
