Davis C Quentin, Waheed Nadia K, Brigell Mitchell
LKC Technologies, Inc., Gaithersburg, Maryland.
New England Eye Center, Boston, Massachusetts.
Ophthalmol Sci. 2025 Jun 17;5(6):100859. doi: 10.1016/j.xops.2025.100859. eCollection 2025 Nov-Dec.
To characterize the performance of 56 parameters from electroretinography (ERG)/pupillometry, color fundus photography (FP), OCT angiography (OCTA), and ultra-widefield fluorescein angiography (UWF-FA) for predicting which subjects with nonproliferative diabetic retinopathy (NPDR) will progress to vision-threating complications (VTCs) within 48 weeks.
A longitudinal prospective study from 44 trial sites in the United States.
Subjects had moderate-to-severe NPDR and no center-involved diabetic macular edema. Among the 162 subjects, the mean age was 57 years and 58% were male.
Although this study tested an experimental drug, there was no indication of a treatment effect. Results are analyzed over all subjects regardless of study treatment.
Specialized reading centers measured 56 parameters from 4 testing modalities (ERG/pupillometry, FP, OCTA, and UWF-FA) to evaluate diabetic retinopathy (DR) status. Kaplan-Meier analysis and a Cox proportional hazards model were applied to each parameter to identify significant predictors of progression to VTC, defined as progression to proliferative DR, diabetic macular edema, or treatment thereof.
Of the 56 parameters, the strongest predictor of progression in the following 48 weeks was the RETeval DR score, which combines ERG and pupil response. A DR score ≥26.9 had a relative risk (RR) of 5.6 ( < 0.0001). The most predictive parameter from the other modalities were UWF-FA's total ischemia index ≥0.125 with an RR of 5.3 ( < 0.0001), OCTA's foveal avascular zone area ≥0.295 mm with an RR of 3.6 ( < 0.05), and FP's diabetic retinopathy severity scale ≥47 (moderate NPDR) with an RR of 2.1 ( < 0.05).
Both functional (ERG, pupil response) and structural (FP, OCTA, UWF-FA) testing can predict progression to VTC from DR, with the DR score having the best predictive capability. These results suggest it is possible to improve the DR staging system which in turn may enable better allocation of health care resources.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
对视网膜电图（ERG）/瞳孔测量、彩色眼底照相（FP）、光学相干断层扫描血管造影（OCTA）和超广角荧光素血管造影（UWF-FA）的56项参数进行特征分析，以预测哪些非增殖性糖尿病视网膜病变（NPDR）患者将在48周内进展为威胁视力的并发症（VTC）。
一项来自美国44个试验地点的纵向前瞻性研究。
受试者患有中度至重度NPDR，且无累及黄斑中心凹的糖尿病性黄斑水肿。在这162名受试者中，平均年龄为57岁，58%为男性。
尽管本研究测试了一种实验性药物，但未显示出治疗效果。无论研究治疗如何，对所有受试者的结果进行分析。
专业阅片中心测量了4种检测方式（ERG/瞳孔测量、FP、OCTA和UWF-FA）的56项参数，以评估糖尿病视网膜病变（DR）状态。对每个参数应用Kaplan-Meier分析和Cox比例风险模型，以确定进展为VTC的显著预测因素，VTC定义为进展为增殖性DR、糖尿病性黄斑水肿或对其进行治疗。
在56项参数中，在接下来48周内进展的最强预测因素是RETeval DR评分，该评分结合了ERG和瞳孔反应。DR评分≥26.9时，相对风险（RR）为5.6（<0.0001）。其他检测方式中最具预测性的参数分别为：UWF-FA的总缺血指数≥0.125，RR为5.3（<0.0001）；OCTA的黄斑无血管区面积≥0.295平方毫米，RR为3.6（<0.05）；FP的糖尿病视网膜病变严重程度量表≥47（中度NPDR），RR为2.1（<0.05）。
功能检测（ERG、瞳孔反应）和结构检测（FP、OCTA、UWF-FA）均可预测DR进展为VTC，其中DR评分的预测能力最佳。这些结果表明有可能改进DR分期系统，进而更好地分配医疗资源。
在本文末尾的脚注和披露中可找到专有或商业披露信息。
