Roski Eye Institute, Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Northern California Retina Vitreous Associates, Mountain View, CA, USA.
BMC Ophthalmol. 2024 May 31;24(1):229. doi: 10.1186/s12886-024-03491-w.
This study evaluated impact of anti-vascular endothelial growth factor (VEGF) treatment on proliferative diabetic retinopathy (PDR) development among patients with non-proliferative diabetic retinopathy (NPDR) in US real-world clinical practice.
This was a retrospective analysis of electronic medical records (Vestrum Health; January 2013 to June 2019) of eyes with baseline NPDR, without DME, and naïve to anti-VEGF treatment at index DR diagnosis. Eyes that received anti-VEGF and/or laser treatment over the course of study before development of PDR constituted the treated cohort while the remaining including those treated with laser constituted the anti-VEGF naïve cohort. Survival analysis via Kaplan-Meier method evaluated time to DME and PDR development by baseline NPDR severity, with anti-VEGF treatment as censoring variable. Baseline factors affecting PDR development were analyzed using Cox multivariable regression, censoring for anti-VEGF treatment.
Among anti-VEGF-naive eyes, cumulative incidence of DME in eyes with mild (n = 70,050), moderate (n = 39,116), and severe NPDR (n = 10,692) at baseline was 27.1%, 51.2%, and 60.6%. Multivariable regression analysis identified baseline NPDR severity as the most significant predictor of PDR development over 48 months (hazard ratio [HR] [95% confidence interval {CI}] of 2.69 (2.65-2.72) for moderate vs mild NPDR and 6.51 (6.47-6.55) for severe vs mild NPDR). Cumulative incidence (95% CI) of PDR was 7.9% (7.4%-8.3%), 20.9%, (20.0%-21.7%) and 46.8% (44.4%-49.2%) over 48 months in eyes with mild, moderate, and severe NPDR at baseline, respectively. Among treated eyes with baseline severe NPDR, cumulative incidence of PDR at 48 months was 50.1% in eyes treated with laser (n = 546; HR [95% CI] vs no treatment: 0.8 [0.7-1.0]), 27.4% in eyes treated with anti-VEGF (n = 923; HR [95% CI]: 0.4 [0.4-0.5]), and 25.6% in eyes treated with anti-VEGF plus laser (n = 293; HR [95% CI]: 0.5 [0.4-0.7]) compared with 49.9% in eyes with no treatment (n = 8930).
DME and PDR development rates increased with increasing baseline NPDR severity. Approximately half of anti-VEGF‒naive eyes with severe NPDR progressed to PDR within 4 years in US clinical practice. The progression rate from severe NPDR to PDR was approximately halved with anti-VEGF versus no treatment.
本研究评估了血管内皮生长因子(VEGF)拮抗剂治疗对美国真实世界临床实践中无增殖性糖尿病视网膜病变(NPDR)患者发生增殖性糖尿病视网膜病变(PDR)的影响。
这是一项回顾性电子病历分析(Vestrum Health;2013 年 1 月至 2019 年 6 月),纳入基线 NPDR、无糖尿病性黄斑水肿(DME)且初次接受抗 VEGF 治疗的患者。在发生 PDR 之前,接受抗 VEGF 和/或激光治疗的眼构成治疗组,而其余接受激光治疗的眼构成抗 VEGF 未治疗组。采用 Kaplan-Meier 法对生存情况进行分析,以基线 NPDR 严重程度作为截尾变量,评估 DME 和 PDR 的发生时间。采用 Cox 多变量回归分析影响 PDR 发生的因素,以抗 VEGF 治疗为截尾变量。
在抗 VEGF 未治疗组中,基线时轻度(n=70050)、中度(n=39116)和重度 NPDR(n=10692)的眼发生 DME 的累积发生率分别为 27.1%、51.2%和 60.6%。多变量回归分析显示,基线 NPDR 严重程度是 48 个月内 PDR 发展的最显著预测因素(中度与轻度 NPDR 相比,HR[95%置信区间]为 2.69[2.65-2.72],重度与轻度 NPDR 相比,HR 为 6.51[6.47-6.55])。基线时 NPDR 轻度、中度和重度的眼在 48 个月内发生 PDR 的累积发生率分别为 7.9%(7.4%-8.3%)、20.9%(20.0%-21.7%)和 46.8%(44.4%-49.2%)。在基线时 NPDR 重度的治疗组中,激光治疗眼(n=546)48 个月时 PDR 的累积发生率为 50.1%(HR[95%CI]与无治疗相比:0.8[0.7-1.0]),抗 VEGF 治疗眼(n=923)为 27.4%(HR[95%CI]:0.4[0.4-0.5]),抗 VEGF 和激光联合治疗眼(n=293)为 25.6%(HR[95%CI]:0.5[0.4-0.7]),而无治疗眼(n=8930)为 49.9%(HR[95%CI]:0.9[0.8-1.0])。
DME 和 PDR 的发生率随基线 NPDR 严重程度的增加而增加。在美国临床实践中,约有一半的基线 NPDR 重度的抗 VEGF 未治疗眼在 4 年内进展为 PDR。与无治疗相比,抗 VEGF 治疗可使 NPDR 进展为 PDR 的速度降低约一半。