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Topical Triamcinolone Acetonide-Loaded Liposome Formulation Used as an Adjuvant to Intravitreal Ranibizumab Therapy for Neovascular Age-Related Macular Degeneration
Pharmaceutics ( IF 5.4 ) Pub Date : 2021-09-17 , DOI: 10.3390/pharmaceutics13091491
Jose Navarro-Partida 1, 2 , Juan Carlos Altamirano-Vallejo 1, 2 , Luis Abraham Aceves Franco 1, 2 , Jesús Gonzalez-Cortes 3 , Sergio Hernandez-Da Mota 4 , Jose Gerardo García-Aguirre 1, 5 , Carlos David Azuara-Galindo 6 , Carlos Rodrigo Castro-Castaneda 1 , Juan Armendariz-Borunda 1, 7 , Arturo Santos 1, 2
Affiliation  

Novel strategies have been developed to reduce or avoid intravitreal injections (IVTs) of the antiangiogenic (ranibizumab (RBZ)) and anti-inflammatory (triamcinolone acetonide (TA)) agents used to treat vitreoretinal diseases. One of the strategies includes liposomes. This study evaluated the safety and efficacy of a topical triamcinolone-loaded liposome formulation (TALF) as an adjuvant to intravitreal RBZ therapy in treatment- naïve patients with neovascular age-related macular degeneration (nAMD). Subjects were randomly assigned to the RBZ-TALF or the RBZ-pro re nata (RBZ-PRN) groups. Patients from the RBZ-TALF group were instructed to apply TALF for 12 months after a single dose of RBZ. Patients from the RBZ-PRN group received three monthly RBZ-IVTs. Retreatment with RBZ was considered in the case of nAMD reactivation. Regarding safety, non-ocular abnormalities were observed during TALF therapy. Concerning efficacy, non-significant differences were identified in terms of visual acuity or central foveal thickness when the RBZ-PRN and RBZ-TALF groups were compared. It is worth noting that the average number of RBZ injections was significantly lower in the RBZ-TALF group (2.5 ± 1.4 vs. 6.1 ± 1.3 IVTs; p = 0.0004). Therefore, TALF used as an adjuvant to RBZ reduces the need for RBZ-IVT retreatment with optimal visual and anatomic results.

中文翻译:

外用曲安奈德负载脂质体制剂用作玻璃体内雷珠单抗治疗新生血管性年龄相关性黄斑变性的辅助剂

已经开发出新的策略来减少或避免用于治疗玻璃体视网膜疾病的抗血管生成(雷珠单抗(RBZ))和抗炎(曲安奈德(TA))药物的玻璃体内注射(IVT)。其中一种策略包括脂质体。本研究评估了外用曲安西龙脂质体制剂 (TALF) 作为玻璃体内 RBZ 治疗辅助治疗新生血管性年龄相关性黄斑变性 (nAMD) 的初治患者的安全性和有效性。受试者被随机分配到 RBZ-TALF 或 RBZ-pro re nata (RBZ-PRN) 组。RBZ-TALF 组的患者被指示在单剂 RBZ 后应用 TALF 12 个月。RBZ-PRN 组的患者每月接受 3 次 RBZ-IVT。在 nAMD 再激活的情况下考虑用 RBZ 再治疗。关于安全,在TALF治疗期间观察到非眼部异常。关于疗效,当比较 RBZ-PRN 和 RBZ-TALF 组时,在视力或中央凹厚度方面发现非显着差异。值得注意的是,RBZ-TALF 组的 RBZ 注射平均次数明显较低(2.5 ± 1.4 vs. 6.1 ± 1.3 IVT;p = 0.0004)。因此,将 TALF 用作 RBZ 的佐剂可减少对 RBZ-IVT 再治疗的需求,从而获得最佳的视觉和解剖结果。
更新日期:2021-09-17
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