Purpose

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).

Design

Post hoc analyses of randomized, multicenter clinical trial data.

Participants

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.

Methods

Intravitreous ranibizumab (0.5 mg/0.05 ml) or PRP.

Main Outcome Measures

Change in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years.

Results

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_1c 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_1c 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).

Conclusions

For eyes managed with PRP, higher hemoglobin A_1c 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.

中文翻译：

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全视网膜光凝与雷珠单抗治疗增生性糖尿病视网膜病变

目的

在使用兰尼单抗或全视网膜光凝（PRP）治疗增生性糖尿病视网膜病变（PDR）的过程中，确定在2年内与视力变化或视力受损中枢性糖尿病性黄斑水肿（DME）发生发展相关的基线因素。

设计

对随机，多中心临床试验数据进行事后分析。

参加者

在糖尿病视网膜病变临床研究网络协议S中，完成2年随访（n = 328）或基线时无视力受损的中心性DME（n = 302）的眼睛。

方法

玻璃体内兰尼单抗（0.5 mg / 0.05 ml）或PRP。

主要观察指标

在两年内，涉及中心的DME的视力变化（曲线下面积）和视力障碍（20/32或更差）的发展。

结果

在对基线视敏度和中央亚视场厚度进行了调整的多变量模型选择之后，在兰尼单抗组内未发现与视敏度变化或视力受损的中央累及DME有关的相关因素。在PRP组中，更高的血红蛋白A _1c水平（每增加1％增加–0.6个字母； 95％置信区间[CI]，从-1.2到–0.1个字母；连续P  = 0.03）时，视力的变化更有可能发生严重的糖尿病性视网膜病变（高风险PDR或较差与中度PDR或更好之间的差异，–2.8字母[95％CI，–5.5至–0.2字母]；连续P = 0.003）和更高的平均动脉压（≥100 mmHg与<100 mmHg之间的差，–2.0个字母（95％CI，–4.6到0.5个字母）；连续P  = 0.009）。较高的血红蛋白A _1c水平（较之每增加1％的危险比[HR]，1.31 [95％CI，1.13–1.52]；持续P <0.001），更严重的糖尿病性视网膜病变更可能导致视力受损的中枢性DME的发展。（高危PDR或中度PDR或更高的HR，为1.46 [95％CI，0.73-2.92]；连续P  = 0.03），并且在黄斑中心500μm以内存在囊样异常（HR，2.90 [95％CI，1.35-6.24]；P  = 0.006）。

结论

对于接受PRP处理的眼睛，较高的血红蛋白A _1c水平和更严重的糖尿病性视网膜病变与视力改善较少和视力损害中枢性DME发生风险增加有关。使用兰尼单抗治疗PDR时，平均而言，眼睛获得了视力，没有基线特征被确定为与视敏度或中枢性DME结果相关。