Valentim Carolina C S, Singh Rishi P, Du Weiming, Moini Hadi, Talcott Katherine E
Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Regeneron Pharmaceuticals, Inc, Tarrytown, New York.
Ophthalmol Retina. 2023 Jan;7(1):24-32. doi: 10.1016/j.oret.2022.07.004. Epub 2022 Jul 14.
To assess the relationship between baseline factors and time to diabetic macular edema (DME) resolution.
Post hoc analysis of VISTA and VIVID.
Eyes with baseline central subfield thickness (CST) of ≥ 290 μm.
Eyes were treated with intravitreal aflibercept injection (IAI) 2 mg (n = 558; every 4 weeks or every 8 weeks after 5 monthly doses) or laser control (n = 274). The effect of baseline factors on the time to DME resolution (CST < 290 μm) was assessed in univariable and multivariable models and further evaluated by the Kaplan-Meier method.
Time to and cumulative incidence of DME resolution.
Eyes treated with IAI had a 2.5-fold higher DME resolution rate, with median time of 33.0 weeks (95% confidence interval [CI], 28.1-40.0), compared with DME resolution not being achieved in 50% of eyes treated with laser control. Multivariable analysis demonstrated that a lower DME resolution rate was associated with a thicker baseline CST (hazard ratio [HR] [95% CI] per 100-μm CST increase, 0.79 [0.72-0.86]) and better baseline best-corrected visual acuity (BCVA) (HR [95% CI] per 5-letter increase, 0.87 [0.83-0.92]) with IAI. Tertiles of increasing CST (T1 ≤ 419 μm; T2 > 419 to ≤ 541; T3 > 541) were associated with longer median times to DME resolution (20.1, 39.1, and 49.1 weeks, respectively; P < 0.001 for T2 and T3 versus T1) and lower cumulative incidence of events (HR, 1.0, 0.6, and 0.6, respectively; P < 0.001 for T2 and T3 versus T1) with IAI. Tertiles of increasing BCVA (T1 ≤ 57 letters; T2 > 57 to ≤ 66; T3 >66) were associated with longer median times to DME resolution (28.4, 31.7, and 44.1 weeks, respectively; P < 0.05 for T3 versus T1) and lower cumulative incidence of events (HR, 1.0, 0.9, and 0.8, respectively; P < 0.05 for T3 versus T1) with IAI. No other baseline factor was associated with the time to DME resolution.
The median time to DME resolution was 33 weeks among IAI-treated eyes. A thicker baseline CST and better baseline BCVA in the IAI group were associated with a longer time to and a lower rate of DME resolution.
评估基线因素与糖尿病性黄斑水肿(DME)消退时间之间的关系。
VISTA和VIVID研究的事后分析。
基线中心子野厚度(CST)≥290μm的眼睛。
眼睛接受2mg玻璃体内阿柏西普注射(IAI)治疗(n = 558;每4周或在5次每月剂量后每8周注射一次)或激光对照治疗(n = 274)。在单变量和多变量模型中评估基线因素对DME消退时间(CST < 290μm)的影响,并通过Kaplan-Meier方法进一步评估。
DME消退时间和累积发生率。
与接受激光对照治疗的眼睛中有50%未实现DME消退相比,接受IAI治疗的眼睛DME消退率高2.5倍,中位时间为33.0周(95%置信区间[CI],28.1 - 40.0)。多变量分析表明,较低的DME消退率与基线CST较厚(每增加100μm CST,风险比[HR][95%CI]为0.79[0.72 - 0.86])以及IAI治疗时基线最佳矫正视力(BCVA)较好(每增加5个字母,HR[95%CI]为0.87[0.83 - 0.92])相关。CST增加的三分位数(T1≤419μm;T2>419至≤541;T3>541)与IAI治疗时DME消退的中位时间更长(分别为20.1、39.1和49.1周;T2和T3与T1相比,P < 0.001)以及事件累积发生率更低(HR分别为1.0、0.6和0.6;T2和T3与T1相比,P < 0.001)相关。BCVA增加的三分位数(T1≤57个字母;T2>57至≤66;T3>66)与IAI治疗时DME消退的中位时间更长(分别为28.4、31.7和44.1周;T3与T1相比,P < 0.05)以及事件累积发生率更低(HR分别为1.0、0.9和0.8;T3与T1相比,P < 0.05)相关。没有其他基线因素与DME消退时间相关。
在接受IAI治疗的眼睛中,DME消退的中位时间为33周。IAI组中基线CST较厚和基线BCVA较好与DME消退时间更长和消退率更低相关。