Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia; Emory Global Health Institute, Emory University, Atlanta, Georgia.
Northern California Retina Vitreous Associates, Mountain View, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Ophthalmology. 2020 Jul;127(7):948-955. doi: 10.1016/j.ophtha.2020.01.006. Epub 2020 Jan 10.
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).
Phase 3 masked, randomized trial.
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.
Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 and week 12.
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.
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 μm versus 18 μm (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).
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.
将药物疗法注射到脉络膜上腔（巩膜和脉络膜之间）是一种替代的给药技术，其开发的原理是与其他眼内和眼周注射程序相比，为后眼部结构提供更高的药物浓度。本研究旨在评估 CLS-TA（曲安奈德乙酰丙酮的混悬液）经脉络膜注射的安全性和疗效，以改善由黄斑水肿（ME）引起的非感染性葡萄膜炎患者的视力。
3 期盲法、随机试验。
160 名 ME 继发于非感染性葡萄膜炎的患者。患者需要有最佳矫正视力（BCVA）为 5 个或更多的早期治疗糖尿病视网膜病变研究（ETDRS）字母（Snellen 等价物，20/800）和 70 个或更少的 ETDRS 字母在研究眼中读取（Snellen 等价物，20/40）。
患者按 3:2 随机分为经脉络膜注射 CLS-TA 或假治疗组，在第 0 天和第 12 周进行给药。
主要终点是在第 24 周时 BCVA 从基线改善 15 个或更多 ETDRS 字母。次要终点是第 24 周时中央小凹厚度（CST）从基线的减少。
在 CLS-TA 组中，47%的患者在 BCVA 中获得 15 个或更多 ETDRS 字母，而对照组为 16%（P<0.001），达到主要终点。与基线相比，CST 的平均减少量为 153μm 对 18μm（P<0.001）。未报告与治疗相关的严重不良事件（AE）。CLS-TA 组和对照组的眼压升高相关的皮质类固醇 AE 发生率分别为 11.5%和 15.6%。白内障 AE 发生率相似（分别为 7.3%和 6.3%）。
CLS-TA 研究组的患者在视力方面较假手术组有明显改善，证明了 CLS-TA 经脉络膜注射治疗威胁视力的 ME 的疗效。
