Singer Michael, Liu Mimi, Schlottmann Patricio G, Khanani Arshad M, Hemphill Miranda, Hill Lauren, Tuomi Lisa, Haskova Zdenka
Medical Center Ophthalmology Associates, San Antonio, TX, USA.
Colorado Retina Associates, Denver, CO, USA.
Clin Ophthalmol. 2020 Jun 17;14:1629-1639. doi: 10.2147/OPTH.S247061. eCollection 2020.
To investigate the predictors of early diabetic retinopathy (DR) improvement in the RIDE/RISE (NCT00473382/NCT00473330) clinical trials.
In RIDE/RISE, adult patients with vision loss due to diabetic macular edema (DME) were randomized to monthly intravitreal ranibizumab 0.3 or 0.5 mg (n=502 total) or sham (n=257). DR severity was graded (using the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale). In this post hoc analysis of RIDE/RISE, eyes with baseline DR score ≥35 were evaluated for ≥2-step improvements, and eyes with baseline DR score ≥43 were evaluated for ≥3-step improvements. The characteristics associated with ≥2- or ≥3-step DR improvement at months 3 or 6 were assessed using univariate and/or multivariable analyses.
The percentage of eyes with a ≥2- or ≥3-step DR improvement was 20.1% and 3.7% at month 3 and 31.2% and 5.8% at month 6. Odds of ≥2-step DR improvement at months 3 or 6 were significantly greater in eyes with moderately severe to severe nonproliferative DR (NPDR) at baseline versus less severe or more severe DR (both <0.0001). At month 6, odds of ≥2-step DR improvement were significantly greater in eyes with no DME at month 3 (=0.008). Most patients with ≥3-step DR improvement at months 3 or 6 had proliferative DR (PDR) at baseline (83.3% and 66.7%).
The strongest predictors of DR response to ranibizumab at month 6 were baseline DR severity and DME quiescence at month 3. Eyes with the most robust early improvements had moderately severe or severe NPDR or PDR at baseline.
在RIDE/RISE（NCT00473382/NCT00473330）临床试验中研究早期糖尿病视网膜病变（DR）改善的预测因素。
在RIDE/RISE试验中，因糖尿病性黄斑水肿（DME）导致视力丧失的成年患者被随机分为每月玻璃体内注射0.3或0.5毫克雷珠单抗组（共502例）或假注射组（257例）。DR严重程度进行分级（使用早期治疗糖尿病视网膜病变研究糖尿病视网膜病变严重程度量表）。在RIDE/RISE的这项事后分析中，对基线DR评分≥35的眼进行≥2级改善评估，对基线DR评分≥43的眼进行≥3级改善评估。使用单变量和/或多变量分析评估在第3或6个月时与DR≥2级或≥3级改善相关的特征。
在第3个月时，DR有≥2级或≥3级改善的眼的百分比分别为20.1%和3.7%，在第6个月时分别为31.2%和5.8%。与基线时轻度至重度非增殖性DR（NPDR）相比，基线时中度至重度NPDR的眼在第3或6个月时DR≥2级改善的几率显著更高（均P<0.0001）。在第6个月时，第3个月无DME的眼DR≥2级改善的几率显著更高（P=0.008）。在第3或6个月时DR有≥3级改善的大多数患者基线时患有增殖性DR（PDR）（分别为83.3%和66.7%）。
第6个月时DR对雷珠单抗反应的最强预测因素是基线DR严重程度和第3个月时DME静止状态。早期改善最显著的眼基线时患有中度至重度NPDR或PDR。
