Protocol H_Proof of Concept Analysis

This work presents a mathematical model designed to optimize anti‑VEGF injection intervals for diabetic macular edema (DME), incorporating systemic factors such as HbA1c, blood pressure, and glycemic variability. The proof-of-concept analysis leverages open‑source data from the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol H. Due to dataset limitations, analysis primarily reflects the HbA1c–BP components of the model, while the contribution of glycemic variability could not be assessed. Results highlight the potential of systemic control parameters to inform individualized treatment schedules, with prospective data collection required to fully evaluate the role of glycemic variability.

本研究构建了一款用于优化糖尿病黄斑水肿（diabetic macular edema, DME）抗血管内皮生长因子（anti-VEGF）注射间隔的数学模型，该模型纳入了糖化血红蛋白（HbA1c）、血压及血糖变异性（glycemic variability）等全身因素。本概念验证分析采用了糖尿病视网膜病变临床研究网络（Diabetic Retinopathy Clinical Research Network, DRCR.net）H方案的开源数据。受限于数据集局限性，本次分析主要覆盖模型中糖化血红蛋白与血压相关组分，未能对血糖变异性的贡献进行评估。研究结果显示，全身控制参数可为个体化治疗方案制定提供参考依据，未来需开展前瞻性数据采集工作，以全面评估血糖变异性在该模型中的作用。