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

在这个开放标签I/II期试验中，五名参与者中有两名（40%）符合研究方案定义的治疗成功标准（第1周OCT测量的中心厚度至少减少25%）。在第1周和第2周，参与者的研究眼睛的中心厚度总体平均减少13%（减少102%至增加54%）和10%（减少106%至增加108%）。在本报告所述期间，本IND项下未报告任何不良事件。研究眼视力的变化（早期治疗糖尿病视网膜病变研究ETDRS总阅读字母）在第1周从基线减少7个字母到增加6个字母（平均增加0.20个字母），在第2周从基线减少10个字母到增加13个字母（平均增加4个字母）。同伴视力的变化范围从第一周减少1个字母到增加10个字母（平均增加1.60个字母），从第2周减少2个字母到增加15个字母（平均阅读3.2个字母）。在第1周，研究眼IOP的变化范围从-2 mmHg到3 mmHg（平均变化0.40 mmHg），在第2周，变化范围从-1 mmHg到2 mmHg（平均变化0.40 mmHg）。第1周眼内眼压变化范围从-14 mmHg到3 mmHg（平均变化-1.60 mmHg），第2周从-15 mmHg到4 mmHg（平均变化-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.