Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Jaeb Center for Health Research, Tampa, Florida.
Ophthalmology. 2018 Nov;125(11):1776-1783. doi: 10.1016/j.ophtha.2018.04.039. Epub 2018 Jul 3.
To identify baseline factors associated with change in visual acuity or development of vision-impairing central-involved diabetic macular edema (DME) over 2 years when treating proliferative diabetic retinopathy (PDR) with ranibizumab or panretinal photocoagulation (PRP).
Post hoc analyses of randomized, multicenter clinical trial data.
Eyes completing the 2-year visit (n = 328) or without vision-impairing central-involved DME at baseline (n = 302) in Diabetic Retinopathy Clinical Research Network Protocol S.
Intravitreous ranibizumab (0.5 mg/0.05 ml) or PRP.
Change in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years.
After multivariable model selection with adjustment for baseline visual acuity and central subfield thickness, no factors were identified as associated with change in visual acuity or development of vision-impairing central-involved DME within the ranibizumab group. In the PRP group, worse change in visual acuity was more likely with higher hemoglobin A level (-0.6 letters per 1% increase; 95% confidence interval [CI], -1.2 to -0.1 letters; continuous P = 0.03), more severe diabetic retinopathy (difference between high-risk PDR or worse vs. moderate PDR or better, -2.8 letters [95% CI, -5.5 to -0.2 letters]; continuous P = 0.003), and higher mean arterial pressure (difference between ≥100 mmHg vs. <100 mmHg, -2.0 letters [95% CI, -4.6 to 0.5 letters]; continuous P = 0.009). Development of vision-impairing central-involved DME was more likely with higher hemoglobin A level (hazard ratio [HR] per 1% increase, 1.31 [95% CI, 1.13-1.52]; continuous P < 0.001), more severe diabetic retinopathy (HR for high-risk PDR or worse vs. moderate PDR or better, 1.46 [95% CI, 0.73-2.92]; continuous P = 0.03), and the presence of cystoid abnormalities within 500 μm of the macula center (HR, 2.90 [95% CI, 1.35-6.24]; P = 0.006).
For eyes managed with PRP, higher hemoglobin A level and more severe diabetic retinopathy were associated with less vision improvement and an increased risk of vision-impairing central-involved DME developing. When managing PDR with ranibizumab, eyes gained vision, on average, with no baseline characteristics identified as associated with visual acuity or central-involved DME outcomes.
在使用雷珠单抗或全视网膜光凝（PRP）治疗增生型糖尿病性视网膜病变（PDR）时，确定与治疗后 2 年内视力变化或出现视力受损的中心性糖尿病性黄斑水肿（DME）相关的基线因素。
随机、多中心临床试验数据的事后分析。
完成 2 年访视（n=328）或基线时无视力受损的中心性 DME（n=302）的糖尿病视网膜病变临床研究网络方案 S 眼。
玻璃体内注射雷珠单抗（0.5 mg/0.05 ml）或 PRP。
2 年内视力（曲线下面积）的变化和视力受损的（20/32 或更差）中心性 DME 的发生。
在经过多变量模型选择和基线视力和中心区厚度的调整后，在雷珠单抗组中，没有发现与视力变化或出现视力受损的中心性 DME 相关的因素。在 PRP 组中，血红蛋白 A 水平升高（每增加 1%，视力下降 0.6 个字母；95%置信区间[CI]，-1.2 至-0.1 个字母；连续 P=0.03）、糖尿病视网膜病变更严重（高危 PDR 或更差与中度 PDR 或更好之间的差异，-2.8 个字母[95%CI，-5.5 至-0.2 个字母]；连续 P=0.003）和平均动脉压更高（≥100 mmHg 与<100 mmHg 之间的差异，-2.0 个字母[95%CI，-4.6 至 0.5 个字母]；连续 P=0.009）与更差的视力改善相关。血红蛋白 A 水平升高（每增加 1%，风险比[HR]为 1.31[95%CI，1.13-1.52]；连续 P<0.001）、糖尿病视网膜病变更严重（高危 PDR 或更差与中度 PDR 或更好之间的 HR 为 1.46[95%CI，0.73-2.92]；连续 P=0.03）和黄斑中心 500 μm 范围内存在囊样变性（HR，2.90[95%CI，1.35-6.24]；P=0.006）与视力受损的中心性 DME 发展的风险增加相关。
对于接受 PRP 治疗的眼睛，较高的血红蛋白 A 水平和更严重的糖尿病视网膜病变与视力改善较少和视力受损的中心性 DME 发展风险增加相关。当使用雷珠单抗治疗 PDR 时，眼睛平均获得视力，没有发现与视力或中心性 DME 结果相关的基线特征。
