2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.
Attikon University Hospital, 1, Rimini Street, 12462, Haidari, Greece.
Acta Diabetol. 2020 Oct;57(10):1219-1225. doi: 10.1007/s00592-020-01548-y. Epub 2020 May 29.
To compare intravitreal ranibizumab as monotherapy or in combination with panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME) in a long-term follow-up of 24 months.
Participants in this prospective study were 47 patients with PDR and concurrent DME, who were randomized at baseline into two groups: (i) the "ranibizumab alone" group (n = 23), which was treated with at least 3 intravitreal ranibizumab injections as a loading phase, and (ii) the "combination" group (n = 24), which was treated with PRP and at least 3 intravitreal ranibizumab injections. Thereafter, all patients were followed up at a pro re nata (PRN) basis, with regular monthly monitoring for 24 months. At each visit, best corrected visual acuity (BCVA) and spectral domain-optical coherence tomography were performed, while regression of neovascularization was also recorded.
The "combination" group had better control of neovascularization and less events of vitreous hemorrhage than ranibizumab alone through the 2 years. BCVA did not differ significantly between the two groups at months 12 and 24 of the follow-up. The "ranibizumab" alone group presented greater reduction in central retinal thickness at month 12, which did not reach significance at month 24 compared to "combination" group. Greater number of injections was needed in the monotherapy group (mean 14 injections) compared to "combination" group (mean 11 injections) through month 24.
Both intravitreal ranibizumab alone or in combination with PRP could be used effectively for the treatment of PDR and coexistent DME. Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.
比较增生性糖尿病视网膜病变（PDR）合并糖尿病性黄斑水肿（DME）患者接受单纯玻璃体腔内雷珠单抗治疗或联合全视网膜光凝（PRP）治疗的长期疗效（24 个月）。
本前瞻性研究纳入 47 例 PDR 合并 DME 患者，按基线分为两组：（i）“雷珠单抗单药治疗”组（n=23），接受至少 3 次玻璃体腔内雷珠单抗注射作为负荷期治疗；（ii）“联合治疗”组（n=24），接受 PRP 联合至少 3 次玻璃体腔内雷珠单抗注射。此后，所有患者均接受按需（PRN）治疗方案随访 24 个月，每月定期监测。每次随访时均行最佳矫正视力（BCVA）和频域光学相干断层扫描（OCT）检查，并记录新生血管消退情况。
在 2 年的随访过程中，“联合治疗”组对新生血管的控制效果更好，玻璃体积血事件更少。在第 12 和 24 个月的随访时，两组的 BCVA 无显著差异。与“联合治疗”组相比，“雷珠单抗单药治疗”组在第 12 个月时中央视网膜厚度（CRT）下降更明显，但在第 24 个月时差异无统计学意义。在第 24 个月时，“雷珠单抗单药治疗”组的注射次数（平均 14 次）多于“联合治疗”组（平均 11 次）。
玻璃体腔内雷珠单抗单独或联合 PRP 均可有效治疗 PDR 合并 DME。虽然在 24 个月的随访时两组间的 BCVA 和 CRT 无差异，但联合治疗组的新生血管消退更明显，所需注射次数更少。
