Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.
Jaeb Center for Health Research, Tampa, Florida.
Retina. 2023 Apr 1;43(4):616-623. doi: 10.1097/IAE.0000000000003730.
BACKGROUND/PURPOSE: To define "strong" versus "weak" antivascular endothelial growth factor (anti-VEGF) treatment response in eyes with center-involved diabetic macular edema (CI-DME).
Exploratory analyses of three DRCR Retina Network randomized trials of eyes with CI-DME treated with aflibercept, bevacizumab, or ranibizumab. Thresholds of 5-, 10-, and 15-letter gain defined strong visual acuity (VA) response when baseline VA was 20/25-20/32, 20/40-20/63, or 20/80-20/320, respectively. Thresholds of 50, 100, or 200- µ m reduction defined strong anatomical response when baseline central subfield thickness (CST) was <75, ≥75 to <175, or ≥175- µ m above standard thresholds. Additional thresholds from regression equations were calculated.
At 24 weeks, outcomes for strong response were achieved by 476 of 958 eyes (50%) for VA and 505 eyes (53%) for CST. At 104 weeks among the 32% of eyes with strong VA and CST response at 24 weeks, 195 of 281 (69%) maintained strong VA and CST response, whereas 20 (7%) had neither strong VA nor strong CST response. Outcomes rates were similar across protocols and when defined using regression equations.
These phenotypes are suitable for efforts to identify predictive biomarkers for response to anti-VEGF therapy for DME and might facilitate comparison of treatment response among diverse cohorts with DME.
背景/目的:在中心性糖尿病黄斑水肿(CI-DME)的眼中,定义“强”与“弱”抗血管内皮生长因子(anti-VEGF)治疗反应。
对接受 aflibercept、bevacizumab 或 ranibizumab 治疗的 CI-DME 眼进行了三个 DRCR 视网膜网络随机试验的探索性分析。当基线视力(VA)为 20/25-20/32、20/40-20/63 或 20/80-20/320 时,5、10 和 15 个字母增益的阈值分别定义为强视力(VA)反应。当基线中央区视网膜厚度(CST)<75µm、≥75-<175µm 或≥175µm 高于标准阈值时,50、100 或 200-µm 减少的阈值分别定义为强解剖学反应。还计算了来自回归方程的其他阈值。
在 24 周时,50%(476/958 只眼)的 VA 和 53%(505 只眼)的 CST 达到了强反应的结局。在 24 周时具有强 VA 和 CST 反应的 32%的眼中,104 周时 195/281(69%)保持了强 VA 和 CST 反应,而 20/281(7%)既没有强 VA 也没有强 CST 反应。在不同的协议中以及使用回归方程定义时,结果率相似。
这些表型适合于识别 DME 抗 VEGF 治疗反应的预测生物标志物的努力,并且可能有助于比较不同 DME 队列的治疗反应。