From the Ophthalmic Consultants of Long Island (Donnenfeld), Garden City, New York, Carolina Eye Care Physicians, LLC (Solomon), West Ashley and North Charleston, South Carolina, and Matossian Eye Associates (Matossian), Doylestown, Pennsylvania, USA.
From the Ophthalmic Consultants of Long Island (Donnenfeld), Garden City, New York, Carolina Eye Care Physicians, LLC (Solomon), West Ashley and North Charleston, South Carolina, and Matossian Eye Associates (Matossian), Doylestown, Pennsylvania, USA.
J Cataract Refract Surg. 2018 Oct;44(10):1236-1246. doi: 10.1016/j.jcrs.2018.07.015. Epub 2018 Aug 20.
To compare the safety and efficacy of IBI-10090 anterior chamber intracameral dexamethasone drug-delivery suspension (Dexycu) with those of prednisolone acetate 1.0% ophthalmic drops in treating inflammation after cataract surgery.
Eleven centers in the United States.
Prospective randomized open-label multicenter trial.
Patients were randomized 2:1 to receive a 5 μL injection of 517 μg IBI-10090 in the anterior eye chamber or topical prednisolone 1.0% drops (1 drop 4 times daily for 3 weeks). The postoperative follow-up was 90 days. The primary outcome was safety, evaluated by the incidence and severity of adverse events. Exploratory measures were anterior chamber cell, anterior chamber flare, and anterior chamber cell-flare clearing.
One hundred twenty-six IBI-10090 patients and 55 prednisolone patients were included in the safety analysis. Two serious adverse events unrelated to treatment were reported. The decrease in endothelial cell density was not significantly different between groups. The most common adverse events were increased intraocular pressure (11.1%), iritis (6.3%), and systemic (7.9% IBI-10090 group; 10.9% prednisolone group). By 8 days postoperatively, 51.6% of IBI-10090 eyes and 50.9% of prednisolone eyes had anterior chamber cell clearing; more than 98% of eyes had clearing at 90 days. The anterior chamber flare and anterior chamber cell-flare clearing results were similar. Of IBI-10090 patients, 68.7% strongly agreed that not having to use eyedrops was very convenient; 39.2% using prednisolone 1.0% strongly stated they would have preferred dropless therapy.
The safety and efficacy of IBI-10090 and prednisolone 1.0% were similar, with IBI-10090 preferred over drops.
比较 IBI-10090 前房内玻璃体内地塞米松药物输送悬浮液（Dexycu）与醋酸泼尼松龙 1.0% 滴眼液在白内障手术后治疗炎症的安全性和疗效。
美国 11 个中心。
前瞻性随机开放标记多中心试验。
患者以 2:1 的比例随机接受 5μL 的 517μg IBI-10090 在前房内注射或局部使用 1.0% 泼尼松龙滴眼液（每日 4 次，共 3 周）。术后随访 90 天。主要结局是安全性，通过不良反应的发生率和严重程度来评估。探索性措施为前房细胞、前房闪烁和前房细胞闪烁清除。
126 名 IBI-10090 患者和 55 名泼尼松龙患者被纳入安全性分析。报告了 2 例与治疗无关的严重不良事件。两组之间内皮细胞密度的下降没有显著差异。最常见的不良事件是眼压升高（11.1%）、虹膜炎（6.3%）和全身（7.9%IBI-10090 组；10.9%泼尼松龙组）。术后 8 天，51.6%的 IBI-10090 眼和 50.9%的泼尼松龙眼的前房细胞清除；90 天时，超过 98%的眼清除。前房闪烁和前房细胞闪烁清除结果相似。在 IBI-10090 患者中，68.7%的患者强烈同意无需使用滴眼液非常方便；39.2%使用泼尼松龙 1.0%的患者强烈表示他们更愿意接受无滴治疗。
IBI-10090 和泼尼松龙 1.0%的安全性和疗效相似，IBI-10090 优于滴眼液。
