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Evaluation of dexamethasone phosphate delivered by ocular iontophoresis for treating noninfectious anterior uveitis

机译：眼电离子透入磷酸地塞米松治疗非感染性前葡萄膜炎的评价

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Purpose: Determine safe, effective, iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in patients with noninfectious anterior uveitis; evaluate systemic drug exposures. Design: Prospective, phase I/II, multicenter, double-masked, parallel group, randomized clinical trial. Participants: Forty outpatients with anterior uveitis. Methods: Forty of 42 randomized patients received an iontophoresis treatment in 1 qualifying eye and completed the study. Patients were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10.0, or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28. Main Outcome Measures: The main outcome measures were anterior chamber cell (ACC) scores at days 14 and 28; time to ACC score of zero; proportion of patients with an ACC score reduction from baseline of <0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS. Results: After a single EGP-437 treatment, 19 of 40 patients (48%) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60%) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an ACC score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65%) had an ACC score reduction from baseline of <0.5 at day 28. The mean change in ACC score from baseline to day 28 was -2.14 with a median of -2.00. Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed. Conclusions: Approximately two thirds of the patients reached an ACC score of zero within 28 days, after only receiving 1 iontophoresis treatment. The lower doses seemed to be the most effective, and treatments were well-tolerated. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
机译：目的：确定非感染性前葡萄膜炎患者EGP-437（磷酸地塞米松用于离子电渗疗法）的安全，有效，离子电渗疗法剂量;评估全身性药物暴露。设计：前瞻性，I / II期，多中心，双盲，平行组，随机临床试验。参与者：40名前葡萄膜炎门诊患者。方法：42名随机分组的患者中有40名接受了离子电渗疗法的一只合格眼的治疗，并完成了研究。将患者随机分为4个离子电渗疗法剂量组（1.6、4.8、10.0或14.0 mA-min）中的1个，通过EyeGate II输送系统（EGDS）用EGP-437治疗，并随访至第28天。主要结果指标：主要结果指标是第14天和第28天的前房细胞（ACC）评分; ACC得分为零的时间;在第28天，ACC评分从基线降低到<0.5的患者比例;第28天时ACC得分相对于基线的平均变化; EGDS-EGP-437治疗后地塞米松和磷酸地塞米松的全身暴露。结果：经过单次EGP-437治疗，40名患者中的19名（48％）在第14天的ACC得分为零。到第28天，40名患者中的24名（60％）的ACC得分为零。 Kaplan-Meier分析表明1.6 mA-min剂量是最有效的，并显示出剂量的反作用。 ACC评分为零的中位数天数在1.6 mA-min组中为11.5天，而在14.0 mA-min组中为31天。 26位患者（65％）的ACC评分在第28天从基线下降到<0.5。从基线到第28天，ACC评分的平均变化为-2.14，中位数为-2.00。在整个研究过程中，平均眼内压保持在正常范围内，并且在4米处的平均最佳矫正视力保持相对稳定。大多数不良事件是轻度的。没有严重不良反应的报道。药代动力学结果表明，电渗疗法后短期全身性地塞米松的暴露较低;没有观察到非眼全身性皮质类固醇介导的作用。结论：仅接受1次离子电渗疗法后，约三分之二的患者在28天内ACC评分为零。较低的剂量似乎是最有效的，并且治疗耐受性良好。财务披露：在参考文献之后可以找到专有或商业披露。

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