Purpose

To report the effectiveness of repeated intravitreal dexamethasone (DEX) inserts in noninfectious uveitis patients.

Design

Prospective, single-center, interventional clinical trial between February 2010 and March 2015.

Participants

Patients with noninfectious uveitis with cystoid macular edema and/or vitreitis.

Methods

Patients were treated with a 700-μg intravitreal DEX insert (Ozurdex; Allergan, Inc., Irvine, CA). Follow-up visits were scheduled 1, 3, and 6 months after injection. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), vitreous haze (VH) score, intraocular pressure (IOP), and adverse events were recorded.

Main Outcome Measures

Primary outcome was the reduction of CRT. Secondary outcome was the improvement in BCVA and reduction of VH.

Results

In total, 109 eyes of 76 patients received 298 DEX inserts. Fifty-two patients were women (68%). The mean age of all participants was 57 years (range, 24–88 years). More than 3 DEX inserts were injected into 44% of eyes. Mean number of injections were 1.54±0.5 (standard deviation [SD]), 1.98±0.84, and 2.46±1.1 over 12, 18, and 24 months, respectively. Central retinal thickness decreased significantly (P < 0.001) from 465 μm at baseline to 318, 342, and 388 μm after 1, 3, and 6 months, respectively. Similar trends were seen in eyes receiving a second, third, and fourth DEX insert. Patients with idiopathic uveitis and sarcoidosis benefited well from DEX inserts. The greatest overall benefit was achieved in patients with no systemic treatment and patients receiving antimetabolites and cyclosporin A. A significant VH score reduction was documented in 44% of eyes after 1 month. A gain of more than 3 lines in BCVA was recorded in 31% to 37%, 26% to 39%, and 8% to 32% of eyes after 1, 3, and 6 months, respectively. A transient rise in mean IOP after 1 month (P < 0.001) and after 3 months (P = 0.001) was seen.

Conclusions

The repeated longer-term administration of DEX inserts in noninfectious uveitis patients, either alone or in combination with other therapies, led to improved CRT, BCVA, and VH. Underlying diseases and concomitant systemic therapy seem to have an impact on overall treatment benefit. Ocular complications were reversible and were managed by local treatment, with exception of cataract formation.

中文翻译：

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地塞米松在非感染性葡萄膜炎中的应用

目的

报告重复玻璃体内地塞米松（DEX）在非感染性葡萄膜炎患者中的有效性。

设计

2010年2月至2015年3月之间的前瞻性，单中心，介入性临床试验。

参加者

非感染性葡萄膜炎合并囊状黄斑水肿和/或玻璃体炎的患者。

方法

患者接受700μg玻璃体内DEX插入物（Ozurdex; Allergan，Inc.，Irvine，CA）的治疗。计划在注射后1、3和6个月进行随访。记录最佳矫正视力（BCVA），视网膜中央厚度（CRT），玻璃体雾度（VH）评分，眼内压（IOP）和不良事件。

主要观察指标

主要结局是降低CRT。次要结果是BCVA改善和VH降低。

结果

总共76例患者的109眼接受了298例DEX插件。52名患者为女性（68％）。所有参与者的平均年龄为57岁（范围为24-88岁）。超过3个DEX插件被注入了44％的眼睛。在12、18和24个月内，平均注射数分别为1.54±0.5（标准差[SD]），1.98±0.84和2.46±1.1。中央视网膜厚度显着降低（P<0.001），从基线的465μm到1、3和6个月后分别为318、342和388μm。在接受第二，第三和第四DEX插入物的眼睛中也看到了类似的趋势。特发性葡萄膜炎和结节病患者从DEX插件中受益匪浅。在未进行全身治疗的患者以及接受抗代谢物和环孢菌素A的患者中，获得了最大的总体收益。据记录，在1个月后，有44％的眼睛的VH评分显着降低。分别在1、3和6个月后，分别有31％至37％，26％至39％和8％至32％的眼睛获得BCVA中超过3条线的增益。1个月后（P <0.001）和3个月后（P  = 0.001），平均眼压出现短暂升高。

结论

在非感染性葡萄膜炎患者中，长期单独或多次与其他疗法联合使用DEX插件可改善CRT，BCVA和VH。潜在疾病和伴随的全身治疗似乎对总体治疗获益产生影响。眼部并发症是可逆的，可以通过局部治疗来解决，但白内障的形成除外。