PURPOSE To assess the safety and efficacy of an intravitreal fluocinolone acetonide (FA) insert to manage inflammation associated with chronic noninfectious posterior uveitis. DESIGN Multicenter, randomized, prospective, doubled-masked, sham-controlled, 3-year phase 3 clinical trial. PARTICIPANTS One hundred twenty-nine participants with recurrent noninfectious posterior uveitis were assigned randomly to FA insert (n = 87) or sham injection (n = 42). The more severely affected eye in participants with bilateral disease was designated as the study eye. METHODS The insert (FA, 0.18 mg) was injected into the vitreous cavity; sham injection mimicked the insert delivery procedure. Ophthalmic examinations, OCT, and ocular tolerability and discomfort assessments were conducted; study visits were on days 7 and 28 and months 2, 3, 6, 9, and 12. Uveitis recurrence was treated as needed. The 6-month recurrence rate was the primary outcome measure. RESULTS The 6-month (28% and 91%) and 12-month (38% and 98%) uveitis recurrence rates were significantly lower (P < 0.001) with FA insert vs. sham, respectively. Fewer recurrences per study eye (mean, 0.7 vs. 2.5), lower incidence of 15-letter or more decrease in best-corrected visual acuity (14% vs. 31%), and reduced systemic (19% vs. 40%) and local (7% vs. 62%) uveitis adjunctive treatments were observed with FA insert vs. sham, respectively. The FA insert group showed higher rates of cataract. Intraocular pressure-lowering treatment use was similar between groups. No deaths, treatment-related study discontinuations, or unanticipated safety signals were observed through 12 months. CONCLUSIONS Chronic noninfectious posterior uveitis was managed successfully in this study population; FA insert eyes experienced fewer uveitis recurrence episodes, required fewer adjunctive treatments, and demonstrated less visual acuity loss compared with sham eyes. The FA insert treatment group showed higher rates of cataract; delivery by injection was not associated with an increase in ocular adverse events or any other safety measures not typically associated with local steroid use, suggesting the procedure is appropriate for an office setting.

中文翻译：

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注射用氟轻松酮乙酰丙酮对慢性非感染性葡萄膜炎复发率的影响后路十二个月。

目的评估玻璃体内氟轻松酮（FA）插入物治疗与慢性非感染性后葡萄膜炎相关的炎症的安全性和有效性。设计多中心，随机，前瞻性，双重掩盖，假对照的3年期3期临床试验。参与者129例复发性非感染性后葡萄膜炎患者随机分配至FA插管（n = 87）或假注射（n = 42）。在患有双侧疾病的受试者中受影响最严重的眼睛被指定为研究眼睛。方法将植入物（FA，0.18 mg）注射入玻璃体腔中。假注射模仿了插入物的输送过程。进行了眼科检查，OCT以及眼部耐受性和不适评估；研究访问分别在第7和28天以及第2、3、6、9和12个月进行。葡萄膜炎复发根据需要进行治疗。6个月的复发率是主要的结局指标。结果与假手术相比，FA插入术的6个月（28％和91％）和12个月（38％和98％）葡萄膜炎复发率显着降低（P <0.001）。每只研究眼的复发次数较少（平均0.7与2.5），最佳矫正视力下降15字母或更多的发生率更低（14％对31％），全身性下降（19％对40％），分别用FA插件与假手术分别观察到局部（7％对62％）葡萄膜炎辅助治疗。FA插入组显示出较高的白内障发生率。两组之间的眼内降压治疗用法相似。在12个月内未观察到死亡，与治疗相关的研究中断或意外的安全信号。结论本研究人群成功治疗了慢性非感染性后葡萄膜炎。与假眼相比，FA插入眼的葡萄膜炎复发次数更少，所需的辅助治疗次数更少，并且视力丧失也更少。FA插入治疗组显示出较高的白内障发生率。注射给药与眼部不良事件的增加或其他通常与局部使用类固醇激素无关的安全措施无关，这表明该方法适合于办公室环境。