Evaluation of an Intravitreal Fluocinolone Acetonide Implant versus Standard Systemic Therapy in Noninfectious Posterior Uveitis
Evaluation of an Intravitreal Fluocinolone Acetonide Implant versus Standard Systemic Therapy in Noninfectious Posterior Uveitis
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DOI：
10.1016/j.ophtha.2009.11.027
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发表时间：
2010-03-01
期刊：
影响因子：
13.7
通讯作者：
Usner, Dale W.
中科院分区：
文献类型：
--
作者：
Pavesio, Carlos;Zierhut, Manfred;Usner, Dale W.
目的：评估玻璃体内注射氟轻松 (FA) 植入物与标准治疗相比，对非感染性后葡萄膜炎 (NIPU) 受试者的安全性和有效性。设计：随机、对照、2b/3 期、开放标签、多中心优越性试验。参与者：单侧或双侧 NIPU 受试者。方法：140 名受试者接受 0.59 mg FA 玻璃体内植入物 (n = 66)或标准护理（SOC；n = 74），全身性泼尼松龙或等效皮质类固醇作为单一疗法（>= 0.2 mg/kg 每日），或者，如果研究者判断有必要，则采用免疫抑制剂加较低剂量的泼尼松龙或等效皮质类固醇（>= 0.1 mg/kg 每日）联合治疗。主要结果指标：葡萄膜炎首次复发的时间。结果：接受 FA 的眼睛玻璃体内植入物观察到的葡萄膜炎复发发生延迟（P < 0.01），且葡萄膜炎复发率较低（18.2% vs. 63.5%；P
Purpose: To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious posterior uveitis (NIPU).Design: Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial.Participants: Subjects with unilateral or bilateral NIPU.Methods: One hundred forty subjects received either a 0.59-mg FA intravitreal implant (n = 66) or standard of care (SOC; n = 74) with either systemic prednisolone or equivalent corticosteroid as monotherapy (>= 0.2 mg/kg daily) or, if judged necessary by the investigator, combination therapy with an immunosuppressive agent plus a lower dose of prednisolone or equivalent corticosteroid (>= 0.1 mg/kg daily).Main Outcome Measures: Time to first recurrence of uveitis.Results: Eyes that received the FA intravitreal implant experienced delayed onset of observed recurrence of uveitis (P < 0.01) and a lower rate of recurrence of uveitis (18.2% vs. 63.5%; P