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 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).

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.

中文翻译：

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脉络膜上CLS-TA治疗继发于非感染性葡萄膜炎的黄斑水肿的疗效和安全性：3期随机试验。

目的

在巩膜和脉络膜之间的脉络膜上腔内注射药物疗法是一种替代性的输注技术，其原理是与其他眼内和眼周注射程序相比，可为眼后结构提供更高的药物浓度。这项研究旨在评估脉络膜上注射曲安奈德的曲安奈德（曲安奈德的混悬液）悬浮液在改善非感染性葡萄膜炎并发黄斑水肿（ME）患者的视力方面的安全性和有效性。

设计

3期掩蔽的随机试验。

参加者

160例继发于非感染性葡萄膜炎的ME患者。要求患者的最佳矫正视力（BCVA）为5个或更多早期治疗性糖尿病视网膜病变研究（ETDRS）字母（相当于Snellen的20/800）和小于等于70个ETDRS字母（相当于Snellen的20/40）在研究眼中。

方法

患者在第0天和第12周随机3：2接受脉络膜上腔注射CLS-TA或假治疗。

主要观察指标

主要终点是在第24周时比BCVA中15个或更多ETDRS字母的基线有所改善。次要终点是在第24周时中心子场厚度（CST）的基线较基线有所降低。

结果

在CLS-TA组中，有47％的患者在BCVA中获得了15个或更多的ETDRS字母，而在对照组中获得了16％（P <0.001），达到了主要终点。与基线相比，CST的平均减少量为153μm，而相对于18μm（P <0.001）。没有报道与治疗有关的严重不良事件。CLS-TA组和对照组的皮质类固醇相关眼压升高的不良事件分别发生在11.5％和15.6％。白内障AE率相当（分别为7.3％和6.3％）。

结论

与假手术相比，CLS-TA研究组的患者的视力在临床上得到了显着改善，证明了脉络膜上腔注射CLS-TA可以有效治疗视力障碍的ME。