Avitabile Teresio, Azzolini Claudio, Bandello Francesco, Boscia Francesco, De Falco Sandro, Fornasari Diego, Lanzetta Paolo, Mastropasqua Leonardo, Midena Edoardo, Ricci Federico, Staurenghi Giovanni, Varano Monica
1 G. Rodolico Ophthalmic, Eye Clinic, University of Catania, Catania - Italy.
2 Department of Medicine and Surgery, University of Insubria, Varese and Como - Italy.
Eur J Ophthalmol. 2017 Nov 8;27(6):627-639. doi: 10.5301/ejo.5001053.
To reach a consensus, among experts, on the role of aflibercept in diabetic macular edema (DME) through literature review.
Two round tables, involving 12 Italian experts, were organized: in the first one, 6 pharmacologic and clinical questions were selected and analyzed by a systematic literature review, using a population, intervention, control, and outcomes framework; in the second one, the nominal group technique was used to discuss relevant evidence related to each question. The consensus was assessed using the 5-point Delphi score.
Agreement on statements was reached on 6/6 questions. The final statements were as follows: 1) High levels of both vascular endothelial growth factor (VEGF) and placental growth factor play an important role in the pathogenesis of DME. 2) The aflibercept pharmacologic profile is notably different from that of other anti-VEGF. 3) Aflibercept significantly improves functional and anatomical outcomes, and rapidly improves best-corrected visual acuity up to its peak; these results remain stable over time. 4) Diabetic macular edema aflibercept treatment requires a 5-monthly injection loading phase. Alternatively, a personalized pro re nata (PRN) regimen based on monthly monitoring and strict retreatment criteria can be used. 5) As an alternative to the bimonthly fixed regimen, in the maintenance phase the treatment schedule may be a PRN regimen with strict retreatment criteria or a treat and extend regimen. 6) No concerns on aflibercept ocular and systemic safety emerged from the literature.
Consensus was reached among experts on how to best treat patients with DME with aflibercept.
通过文献综述，就阿柏西普在糖尿病性黄斑水肿（DME）中的作用在专家间达成共识。
组织了两场圆桌会议，有12位意大利专家参与：在第一场会议中，选取了6个药理学和临床问题，并采用人群、干预措施、对照和结果框架进行系统文献综述分析；在第二场会议中，使用名义组技术讨论与每个问题相关的证据。采用5分制德尔菲评分评估共识。
6个问题均达成了一致意见。最终声明如下：1）血管内皮生长因子（VEGF）和胎盘生长因子水平升高在DME发病机制中起重要作用。2）阿柏西普的药理学特征与其他抗VEGF药物显著不同。3）阿柏西普显著改善功能和解剖学结果，并迅速提高最佳矫正视力直至达到峰值；这些结果随时间保持稳定。4）糖尿病性黄斑水肿阿柏西普治疗需要5个月的注射负荷期。或者，可采用基于每月监测和严格再治疗标准的个性化按需（PRN）方案。5）作为双月固定方案的替代方案，在维持期治疗方案可以是具有严格再治疗标准的PRN方案或治疗并延长方案。6）文献中未发现对阿柏西普眼内和全身安全性的担忧。
专家们就如何使用阿柏西普最佳治疗DME患者达成了共识。
