Department of Ophthalmology, University of Ulm, Ulm, Germany.
Cologne Image Reading Center, Center for Ophthalmology, University of Cologne, Cologne, Germany.
Acta Ophthalmol. 2018 May;96(3):e377-e385. doi: 10.1111/aos.13574. Epub 2017 Nov 1.
To assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser (COMBI) versus laser monotherapy (LASER) in patients with visual impairment due to diabetic macular oedema (DME) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) and to analyse the relevance of inner versus outer retinal thickness.
In this double-masked, multicentre phase IIIb study, patients (N = 128) were randomized (2:1) to receive COMBI (n = 85) versus LASER (n = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg (COMBI) or sham (LASER) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for DME.
The least squares (LS) mean change in mean best-corrected visual acuity (BCVA) from baseline to month 12 was higher in the COMBI (6.5) versus LASER (2.3) group (LS mean difference: 4.2 [95% CI 0.9; 7.4] letters, p = 0.01, primary end-point). There was also a tendency in the same direction for the subgroup of 26 patients with PDR (LS mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3 μm in the COMBI group and by 80.3 μm in the LASER group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated.
This study showed that ranibizumab plus laser is a valuable treatment option for the management of DME. Patients with DME in PDR might also benefit from combined therapy compared to laser alone.
评估玻璃体内注射雷珠单抗 0.5mg 联合激光（COMBI）与单纯激光治疗（LASER）对非增生性糖尿病视网膜病变（NPDR）或增生性糖尿病视网膜病变（PDR）患者因糖尿病性黄斑水肿（DME）导致的视力损害的疗效和安全性，并分析内、外视网膜厚度的相关性。
这是一项双盲、多中心 IIIb 期研究，将 128 例患者（N=128）随机（2:1）分为 COMBI 组（n=85）和 LASER 组（n=43）。患者接受 4 次初始每月注射雷珠单抗 0.5mg（COMBI）或假注射（LASER），然后根据需要进行 pro re nata（PRN）注射。在两组中，患者在基线时接受激光治疗，如有需要，每 3 个月接受一次额外的激光治疗。该研究于 2010 年开始，并因雷珠单抗获得 DME 批准而提前终止。
从基线到第 12 个月，COMBI（6.5）组的平均最佳矫正视力（BCVA）较 LASER（2.3）组的 LS 均值变化更高（LS 均值差异：4.2 [95%CI 0.9; 7.4] 个字母，p=0.01，主要终点）。在 PDR 亚组的 26 例患者中也有同样的趋势（LS 均值差异 14.7，p=0.11）。从基线到第 12 个月，COMBI 组的中央视网膜厚度平均下降 107.3μm，LASER 组下降 80.3μm（p=0.28）。雷珠单抗耐受性良好。
本研究表明，雷珠单抗联合激光治疗是 DME 治疗的一种有价值的选择。与单纯激光治疗相比，PDR 合并 DME 的患者可能也从联合治疗中受益。
