Alagorie Ahmed Roshdy, Velaga Swetha, Nittala Muneeswar Gupta, Yu Hannah J, Wykoff Charles C, Sadda Srinivas R
Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California; Department of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.
Ophthalmol Retina. 2021 May;5(5):409-419. doi: 10.1016/j.oret.2020.08.018. Epub 2020 Sep 1.
To evaluate the effect of intravitreal aflibercept on diabetic retinopathy (DR) severity and visual function in patients with proliferative DR (PDR) without diabetic macular edema (DME).
Prospective, longitudinal, multicenter clinical trial.
Forty eyes of 40 patients with PDR and no DME were enrolled in this study. Patients were randomized into monthly and quarterly 2-mg aflibercept injection cohorts and were treated over a period of 12 months.
All patients underwent ultra-widefield fundus imaging including pseudocolor and fluorescein angiography using an Optos 200Tx device.
Severity of DR at baseline, month 6, and month 12 was evaluated using the DR severity scale (DRSS). The DRSS scores were correlated with the 25-item Visual Function Questionnaire (VFQ-25) and 39-item Visual Function Questionnaire (VFQ-39) scores at baseline and month 12.
Mean age of the patients was 48.2 years (range, 25-75 years), mean duration of diabetes mellitus was 16.1 years (range, 2-36 years), and median glycated hemoglobin level was 8.8% (IQR, 7.4%-10%). Both monthly and quarterly groups demonstrated a statistically significant regression in DRSS from baseline to month 12 (P < 0.001). The monthly group demonstrated a statistically significant greater regression of DRSS score at the month 6 visit compared with the quarterly group (P = 0.019). However, the difference between the two groups became statistically insignificant at month 12 visit (P = 0.309). Also no difference was found in mean VFQ-25 and VFQ-39 composite scores between the monthly and quarterly groups at month 12 (P = 0.947 and P = 0.921, respectively). The improvement in mean VFQ-25 and VFQ-39 composite scores at month 12 was correlated significantly with improvement in DRSS score (r = 0.384 and P = 0.039, and r = 0.361 and P = 0.046, respectively).
In this study of eyes with PDR without DME, both monthly and quarterly aflibercept injection groups showed significant improvement in DR severity at month 12 compared with baseline. The improvement in DRSS score was associated with an improvement in VFQ-25 and VFQ-39 composite score.
评估玻璃体内注射阿柏西普对无糖尿病性黄斑水肿（DME）的增殖性糖尿病视网膜病变（PDR）患者的糖尿病视网膜病变（DR）严重程度及视功能的影响。
前瞻性、纵向、多中心临床试验。
40例无DME的PDR患者的40只眼纳入本研究。患者被随机分为每月和每季度注射2 mg阿柏西普的队列，并接受为期12个月的治疗。
所有患者均使用Optos 200Tx设备进行超广角眼底成像，包括伪彩色和荧光素血管造影。
使用DR严重程度量表（DRSS）评估基线、第6个月和第12个月时DR的严重程度。将DRSS评分与基线和第12个月时的25项视觉功能问卷（VFQ-25）和39项视觉功能问卷（VFQ-39）评分进行相关性分析。
患者的平均年龄为48.2岁（范围25 - 75岁），糖尿病平均病程为16.1年（范围2 - 36年），糖化血红蛋白水平中位数为8.8%（四分位间距，7.4% - 10%）。每月和每季度注射组从基线到第12个月DRSS均有统计学意义的改善（P < 0.001）。与每季度注射组相比，每月注射组在第6个月随访时DRSS评分的改善具有统计学意义（P = 0.019）。然而，在第12个月随访时两组之间的差异无统计学意义（P = 0.309）。在第12个月时，每月和每季度注射组之间的平均VFQ-25和VFQ-39综合评分也无差异（分别为P = 0.947和P = 0.921）。第12个月时平均VFQ-25和VFQ-39综合评分的改善与DRSS评分的改善显著相关（分别为r = 0.384，P = 0.039；r = 0.361，P = 0.046）。
在本项针对无DME的PDR患眼的研究中，每月和每季度注射阿柏西普组与基线相比，在第12个月时DR严重程度均有显著改善。DRSS评分的改善与VFQ-25和VFQ-39综合评分的改善相关。
