Medical Retina Service/Moorfields Eye Hospital, London, UK.
Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.
To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious posterior uveitis (NIPU).
Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial.
Subjects with unilateral or bilateral NIPU.
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 (> or =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 (> or =0.1 mg/kg daily).
Time to first recurrence of uveitis.
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< or =0.01) compared with SOC study eyes. Adverse events frequently observed in implanted eyes included elevated intraocular pressure (IOP) requiring IOP-lowering surgery (occurring in 21.2% of implanted eyes) and cataracts requiring extraction (occurring in 87.8% of phakic implanted eyes). No treatment-related nonocular adverse events were observed in the implant group, whereas such events occurred in 25.7% of subjects in the SOC group.
The FA intravitreal implant provided better control of inflammation in patients with uveitis compared with systemic therapy. Intraocular pressure and lens clarity of implanted eyes need close monitoring in patients receiving the FA intravitreal implant.
评估与标准疗法相比，玻璃体内氟轻松醋酸酯（FA）植入物在非感染性后部葡萄膜炎（NIPU）患者中的安全性和疗效。
随机、对照、2b/3 期、开放性、多中心优效性试验。
单侧或双侧 NIPU 患者。
140 名受试者分别接受 0.59mg FA 玻璃体内植入物（n=66）或标准治疗（SOC；n=74），SOC 治疗包括全身泼尼松龙或等效皮质类固醇作为单药治疗（>或=0.2mg/kg 每日）或，如果研究者认为有必要，联合免疫抑制剂加较低剂量的泼尼松龙或等效皮质类固醇（>或=0.1mg/kg 每日）。
首次葡萄膜炎复发的时间。
接受 FA 玻璃体内植入物治疗的眼睛葡萄膜炎复发的时间延迟（P<0.01），葡萄膜炎复发的发生率较低（18.2%对 63.5%；P<或=0.01），与 SOC 研究眼睛相比。植入眼常观察到的不良反应包括需要降眼压手术的眼压升高（21.2%的植入眼发生）和需要摘除的白内障（87.8%的有晶状体植入眼发生）。植入组未观察到与治疗相关的非眼部不良事件，而 SOC 组中有 25.7%的受试者发生此类事件。
与全身治疗相比，FA 玻璃体内植入物为葡萄膜炎患者提供了更好的炎症控制。接受 FA 玻璃体内植入物治疗的患者需要密切监测眼内压和晶状体清晰度。
