The Wilmer Eye Institute, the Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA.
Ophthalmology. 2011 Apr;118(4):626-635.e2. doi: 10.1016/j.ophtha.2010.12.028.
To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME).
Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials.
Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393).
Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year.
The primary outcome was the percentage of patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH).
The percentage of patients with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively.
Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years.
评估玻璃体内植入物释放 0.2μg/天（低剂量）或 0.5μg/天（高剂量）氟轻松醋酸酯（FA）治疗糖尿病性黄斑水肿（DME）患者的疗效和安全性。
两项平行、前瞻性、随机、假注射对照、双盲、多中心临床试验。
在至少接受 1 次黄斑激光治疗后仍有持续性 DME 的受试者被随机分为 1:2:2 组，分别接受假注射（n=185）、低剂量植入物（n=375）或高剂量植入物（n=393）。
受试者在基线时接受研究药物或假注射，6 周后有资格接受挽救性激光治疗。根据再治疗标准，在 1 年后可以给予额外的研究药物或假注射。
主要终点是在第 24 个月时，根据早期治疗糖尿病视网膜病变试验（ETDRS）字母评分，视力改善（BCVA）至少 15 个字母的患者比例。次要终点包括其他视觉功能和中心凹厚度（FTH）参数。
低剂量和高剂量植入物组在第 24 个月时视力改善（BCVA）达到 ETDRS 字母评分 15 分或以上的患者比例分别为 28.7%和 28.6%，而假注射组为 16.2%（P=0.002 ）。与假注射相比，两种剂量均在第 3 周和所有后续时间点获益。低剂量和高剂量组与基线相比，BCVA 字母评分的平均改善分别为 4.4 和 5.4 个字母，而假注射组为 1.7 个字母（P=0.02 和 P=0.016）。与假注射相比，所有时间点的 FTH 均有显著改善。植入物组中需要白内障手术的患者更为频繁，但他们的视力改善与基线时已经是假晶状体的患者相似。低剂量、高剂量和假注射组分别有 3.7%、7.6%和 0.5%的患者发生需要切开手术的青光眼。
在 2 年的时间里，低剂量和高剂量 FA 植入物都显著改善了 DME 患者的 BCVA，低剂量植入物的风险-效益比更优。这是第一种可以通过门诊注射给药的药物治疗方法，可为至少 2 年的 DME 患者提供实质性获益。
Zotero 插件