Chen-Li Genesis, Martinez-Archer Rebeca, Coghi Andres, Roca José A, Rodriguez Francisco J, Acaba-Berrocal Luis, Berrocal María H, Wu Lihteh
Asociados de Mácula Vitreo y Retina de Costa Rica, San José 60612, Costa Rica.
Oftalmologos Contreras, Lima 15036, Peru.
J Clin Med. 2024 May 9;13(10):2778. doi: 10.3390/jcm13102778.
Complications from diabetic retinopathy such as diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) constitute leading causes of preventable vision loss in working-age patients. Since vascular endothelial growth factor (VEGF) plays a major role in the pathogenesis of these complications, VEGF inhibitors have been the cornerstone of their treatment. Anti-VEGF monotherapy is an effective but burdensome treatment for DME. However, due to the intensive and burdensome treatment, most patients in routine clinical practice are undertreated, and therefore, their outcomes are compromised. Even in adequately treated patients, persistent DME is reported anywhere from 30% to 60% depending on the drug used. PDR is currently treated by anti-VEGF, panretinal photocoagulation (PRP) or a combination of both. Similarly, a number of eyes, despite these treatments, continue to progress to tractional retinal detachment and vitreous hemorrhage. Clearly there are other molecular pathways other than VEGF involved in the pathogenesis of DME and PDR. One of these pathways is the angiopoietin-Tie signaling pathway. Angiopoietin 1 (Ang1) plays a major role in maintaining vascular quiescence and stability. It acts as a molecular brake against vascular destabilization and inflammation that is usually promoted by angiopoietin 2 (Ang2). Several pathological conditions including chronic hyperglycemia lead to Ang2 upregulation. Recent regulatory approval of the bi-specific antibody, faricimab, may improve long term outcomes in DME. It targets both the Ang/Tie and VEGF pathways. The YOSEMITE and RHINE were multicenter, double-masked, randomized non-inferiority phase 3 clinical trials that compared faricimab to aflibercept in eyes with center-involved DME. At 12 months of follow-up, faricimab demonstrated non-inferior vision gains, improved anatomic outcomes and a potential for extended dosing when compared to aflibercept. The 2-year results of the YOSEMITE and RHINE trials demonstrated that the anatomic and functional results obtained at the 1 year follow-up were maintained. Short term outcomes of previously treated and treatment-naive eyes with DME that were treated with faricimab during routine clinical practice suggest a beneficial effect of faricimab over other agents. Targeting of Ang2 has been reported by several other means including VE-PTP inhibitors, integrin binding peptide and surrobodies.
糖尿病视网膜病变的并发症,如糖尿病性黄斑水肿(DME)和增殖性糖尿病视网膜病变(PDR),是导致工作年龄患者可预防性视力丧失的主要原因。由于血管内皮生长因子(VEGF)在这些并发症的发病机制中起主要作用,VEGF抑制剂一直是其治疗的基石。抗VEGF单药治疗是治疗DME的一种有效但负担较重的方法。然而,由于治疗强度大且负担重,大多数常规临床实践中的患者治疗不足,因此其治疗效果受到影响。即使在接受充分治疗的患者中,根据所使用的药物不同,持续性DME的发生率据报道在30%至60%之间。目前,PDR通过抗VEGF、全视网膜光凝(PRP)或两者联合进行治疗。同样,尽管进行了这些治疗,仍有许多眼睛会进展为牵引性视网膜脱离和玻璃体积血。显然,除了VEGF之外,还有其他分子途径参与了DME和PDR的发病机制。其中一条途径是血管生成素-Tie信号通路。血管生成素1(Ang1)在维持血管静止和稳定方面起主要作用。它作为一种分子制动器,对抗通常由血管生成素2(Ang2)促进的血管不稳定和炎症。包括慢性高血糖在内的几种病理状况会导致Ang2上调。双特异性抗体faricimab最近获得监管批准,可能会改善DME的长期治疗效果。它同时作用于Ang/Tie和VEGF途径。YOSEMITE和RHINE试验是多中心、双盲、随机非劣效性3期临床试验,比较了faricimab与阿柏西普在累及中心凹的DME患者眼中的疗效。在12个月的随访中,与阿柏西普相比,faricimab显示出非劣效的视力改善、更好的解剖学效果以及延长给药间隔的可能性。YOSEMITE和RHINE试验的2年结果表明,1年随访时获得的解剖学和功能结果得以维持。在常规临床实践中,用faricimab治疗既往接受过治疗和未接受过治疗的DME患者的短期结果表明,faricimab比其他药物具有更好的疗效。通过其他几种方法,包括血管内皮蛋白酪氨酸磷酸酶(VE-PTP)抑制剂、整合素结合肽和替代抗体,也已报道了针对Ang2的治疗作用。