Lewis Richard A, Christie William C, Day Douglas G, Craven E Randy, Walters Thomas, Bejanian Marina, Lee Susan S, Goodkin Margot L, Zhang Jane, Whitcup Scott M, Robinson Michael R
Sacramento Eye Consultants, Sacramento, California.
Scott & Christie and Associates, Pittsburgh, Pennsylvania.
Am J Ophthalmol. 2017 Mar;175:137-147. doi: 10.1016/j.ajo.2016.11.020. Epub 2016 Dec 22.
To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost sustained-release implant (Bimatoprost SR).
Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial.
At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported.
Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes).
Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months.
评估可生物降解的比马前列素缓释植入物(Bimatoprost SR)的安全性和降眼压(IOP)效果。
I/II期前瞻性、为期24个月的剂量范围、双眼对照临床试验。
在洗脱期后的基线期,对开角型青光眼患者(n = 75)的研究眼进行前房内注射Bimatoprost SR(6μg、10μg、15μg或20μg);对侧眼开始每日一次局部使用0.03%的比马前列素。允许使用挽救性局部降眼压药物或单次重复植入治疗。主要终点是眼压相对于基线的变化。主要安全指标是不良事件。报告了至第6个月的结果。
Bimatoprost SR能快速、持续降低眼压。研究眼中,从基线到第16周,植入物剂量分别为6μg、10μg、15μg和20μg时,眼压总体平均降低值分别为7.2、7.4、8.1和9.5 mmHg,而局部使用比马前列素治疗的对侧眼合并组为8.4 mmHg(在挽救/再治疗时数据被审查)。分别在第16周和第6个月时,91%和71%的研究眼无需进行挽救/再治疗。研究眼中的不良事件通常在注射操作后2天内发生且为短暂性。注射操作后2天以上出现的结膜充血在局部使用比马前列素的眼中比在Bimatoprost SR眼中更常见(分别为17.3%和6.7%的眼)。
Bimatoprost SR在6个月内显示出良好的疗效和安全性。在至第16周的总体眼压降低方面,所有剂量强度与局部使用比马前列素相当。单次给药可使大多数患者的眼压得到控制长达6个月。