The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA.
Ophthalmology. 2010 Jul;117(7):1393-9.e3. doi: 10.1016/j.ophtha.2009.11.024. Epub 2010 Mar 3.
To compare Iluvien intravitreal inserts that release 0.2 or 0.5 microg/day of fluocinolone acetonide (FA) in patients with diabetic macular edema (DME).
Prospective, randomized, interventional, multicenter clinical trial.
We included 37 patients with DME.
Subjects with persistent DME despite > or = 1 focal/grid laser therapy were randomized 1:1 to receive an intravitreal insertion of a 0.2- or a 0.5-microg/day insert.
The primary end point was aqueous levels of FA throughout the study with an important secondary outcome of the change from baseline in best-corrected visual acuity (BCVA) at month 12.
The mean aqueous level of FA peaked at 3.8 ng/ml at 1 week and 1 month after administration of a 0.5-microg/day insert and was 3.4 and 2.7 ng/ml 1 week and 1 month after administration of a 0.2-microg/day insert. For both inserts, FA levels decreased slowly thereafter and were approximately 1.5 ng/ml for each at month 12. The mean change from baseline in BCVA was 7.5, 6.9, and 5.7 letters at months 3, 6, and 12, respectively, after administration of a 0.5 microg/day-insert and was 5.1, 2.7, and 1.3 letters at months 3, 6, and 12, respectively, after administration of a 0.2-microg/day insert. There was a mild increase in mean intraocular pressure after administration of 0.5-microg/day inserts, but not after administration of 0.2-microg/day inserts.
The FA intravitreal inserts provide excellent sustained intraocular release of FA for > or = 1 year. Although the number of patients in this trial was small, the data suggest that the inserts provide reduction of edema and improvement in BCVA in patients with DME with mild effects on intraocular pressure over the span of 1 year.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
比较释放 0.2 或 0.5 微克/天氟轻松醋酸酯 (FA) 的 Iluvien 玻璃体内植入物在糖尿病性黄斑水肿 (DME) 患者中的疗效。
前瞻性、随机、干预性、多中心临床试验。
我们纳入了 37 例 DME 患者。
对接受过 > 或 = 1 次局灶/格栅激光治疗后仍持续存在 DME 的患者进行随机 1:1 分组，分别接受 0.2 或 0.5 微克/天植入物的玻璃体内植入。
主要终点是整个研究过程中的 FA 房水水平，重要的次要终点是治疗 12 个月时最佳矫正视力 (BCVA) 自基线的变化。
接受 0.5 微克/天植入物治疗的患者，FA 的平均房水水平在给药后 1 周和 1 个月时达到峰值，分别为 3.8 纳克/毫升，而接受 0.2 微克/天植入物治疗的患者，分别为 3.4 和 2.7 纳克/毫升。此后，两种植入物的 FA 水平均缓慢下降，在第 12 个月时，每个植入物的 FA 水平约为 1.5 纳克/毫升。接受 0.5 微克/天植入物治疗的患者，自基线的平均 BCVA 变化分别为治疗后 3、6 和 12 个月时的 7.5、6.9 和 5.7 个字母，而接受 0.2 微克/天植入物治疗的患者，分别为 5.1、2.7 和 1.3 个字母。接受 0.5 微克/天植入物治疗后，平均眼压轻度升高，但接受 0.2 微克/天植入物治疗后眼压无升高。
FA 玻璃体内植入物可提供 > 或 = 1 年的 FA 持续稳定眼内释放。尽管本试验的患者数量较少，但数据表明，在 1 年内，植入物可减轻 DME 患者的水肿并改善 BCVA，对眼压的影响较小。
参考文献后可能有专有或商业披露。
