Topical Interferon Gamma for Uveitic macular edema (JAKSTAT2: 11-EI-0167)

在这项开放标签I/II期试验中，5名参与者中有2名（40%）符合研究方案定义的治疗成功标准（第1周OCT测量的中央厚度至少减少25%）。参与者的中央厚度总体平均减少13%（从102%下降到54%上升）和10%在第1周和第2周时，其研究眼的平均眼压（范围从106%降低至108%增加），在本报告期间，在该IND下未报告不良事件。（早期治疗糖尿病视网膜病变研究ETDRS阅读的总字母数）范围为第1周时较基线减少7个字母至增加6个字母（平均增加0.20个字母阅读），范围从第2周时较基线减少10个字母至增加13个字母阅读（平均增加4个字母阅读）。第1周时，对侧眼视力变化范围为减少1个字母至增加10个字母（平均增加1.60个字母），第2周时，对侧眼视力变化范围为减少2个字母至增加15个字母（平均增加3.2个字母）。第1周时研究眼IOP的变化范围为-2 mmHg至3 mmHg（平均变化为0.40 mmHg），第2周时范围为-1 mmHg至2 mmHg（平均变化为0.40 mmHg）。第1周时对侧眼IOP的变化范围为-14 mmHg至3 mmHg（平均变化为-1.60 mmHg），第2周时为-15 mmHg至4 mmHg（平均变化为-2.20 mmHg）。

In this open label phase I/II trial two out of five participants (40%) met the criteria for treatment success as defined by the study protocol (with at least a 25% decrease in central thickness as measured on OCT at Week 1).Participants presented with overall mean decreases in excess central thickness of 13% (ranging from a 102% decrease to a 54% increase) and 10% (ranging from 106% decrease to a 108% increase) in their study eyes at Weeks 1 and 2, respectively.No adverse events have been reported under this IND during the reporting period.Changes in study eye visual acuity (Early Treatment Diabetic Retinopathy Study ETDRS total letters read) ranged from a decrease of 7 letters to an increase of 6 letters read from baseline at Week 1 (mean increase of 0.20 letters read) and ranged from a decrease of 10 letters to an increase in 13 letters read from baseline at Week 2 (mean increase of 4 letters read). Changes in fellow eye visual acuity ranged from a decrease of 1 letter to an increase of 10 letters read at Week 1 (mean increase of 1.60 letters read) and ranged from a decrease of 2 letters to an increase of 15 letters read at Week 2 (mean of 3.2 letters read). Changes in study eye IOP ranged from -2 mmHg to 3 mmHg (mean change of 0.40 mmHg) at Week 1 and ranged from -1 mmHg to 2 mmHg (mean change of 0.40 mmHg) at Week 2. Changes in fellow eye IOP ranged from -14 mmHg to 3 mmHg (mean change of -1.60 mmHg) at Week 1 and ranged from -15 mmHg to 4 mmHg (mean change of -2.20 mmHg) at Week 2.