Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis Phase 3 Randomized Trial
Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis Phase 3 Randomized Trial
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DOI：
10.1016/j.ophtha.2020.01.006
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发表时间：
2020-07-01
期刊：
影响因子：
13.7
通讯作者：
Noronha, Glenn
中科院分区：
文献类型：
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作者：
Yeh, Steven;Khurana, Rahul N.;Noronha, Glenn
目的：在巩膜和脉络膜之间的脉络膜上间隙注射药物是一种替代给药技术，其原理是与其他眼内和眼周注射方法相比，向眼后结构提供更高的药物浓度。本研究旨在评价曲安奈德混悬剂(CLS-TA)在改善非感染性葡萄膜炎合并黄斑水肿(ME)患者视力方面的安全性和有效性。设计：3期掩蔽随机试验。参与者：160例非感染性葡萄膜炎继发ME患者。患者被要求具有5个或更多早期治疗的糖尿病视网膜病变研究(ETDRS)字母(相当于Snellen，20/800)和70个或更少的ETDRS字母(相当于Snellen，20/40)的最佳矫正视力(BCVA)。方法：患者被随机分为3：2组，分别在第0天和第12周接受脉络膜上注射CLS-TA或假治疗。主要观察指标：主要终点是在24周时BCVA中15个或更多ETDRS字母的基线改善。次要终点是24周时中央亚野厚度(CST)较基线的减少。结果：在CLS-TA组，47%的患者在BCVA中获得了15个或更多的ETDRS字母，而对照组(P<；0.001)为16%，达到了主要终点。与基线相比，CST的平均降幅为153µm，而18µm(P<；0.001)。没有与治疗相关的严重不良事件(AEs)的报道。CLS-TA组和对照组中分别有11.5%和15.6%的患者出现高眼压的皮质类固醇相关不良反应。白内障声发射发生率相似(分别为7.3%和6.3%)。结论：与SHAM手术相比，CLS-TA研究组患者的视力有显著改善，证明了CLS-TA脉络膜上注射治疗危及视力的ME的有效性。(C)2020年由美国眼科学会颁发。
Purpose: Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is an alternative delivery technique developed with the rationale of providing higher drug concentrations to posterior ocular structures compared with other intraocular and periocular injection procedures. This study was conducted to evaluate the safety and efficacy of suprachoroidally injected triamcinolone acetonide formulation (CLS-TA), a suspension of triamcinolone acetonide, in improving vision among patients with noninfectious uveitis complicated by macular edema (ME).Design: Phase 3 masked, randomized trial.Participants: One hundred sixty patients with ME secondary to noninfectious uveitis. Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye.Methods: Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 and week 12.Main Outcome Measures: The primary end point was improvement from baseline of 15 or more ETDRS letters in BCVA at week 24. The secondary end point was reduction from baseline in central subfield thickness (CST) at week 24.Results: In the CLS-TA arm, 47% of patients gained 15 or more ETDRS letters in BCVA versus 16% in the control arm (P < 0.001), meeting the primary end point. Mean reductions in CST from baseline were 153 mu m versus 18 mu m (P < 0.001). No serious adverse events (AEs) related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively).Conclusions: Patients in the CLS-TA study arm experienced clinically significant improvement in vision relative to the sham procedure, demonstrating the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder. (C) 2020 by the American Academy of Ophthalmology.