在开角型青光眼或高眼压症患者中单次前房内注射10μg比马前列素植入剂
Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension.
作者信息
Medeiros Felipe A, Sheybani Arsham, Shah Manjool M, Rivas Marcos, Bai Zhanying, Werts Erica, Ahmed Iqbal I K, Craven E Randy
机构信息
Department of Ophthalmology, Duke Eye Center, Duke University, 2351 Erwin Rd, Durham, NC, 27705, USA.
Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, MO, USA.
出版信息
Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
INTRODUCTION
This study evaluated the intraocular pressure (IOP)-lowering efficacy and safety of a single intracameral administration of bimatoprost implant 10 µg in adults with open-angle glaucoma or ocular hypertension.
METHODS
Two identically designed, randomized, 20-month, parallel-group, phase 3 clinical trials (one study eye/patient) compared three administrations of 10- or 15-µg bimatoprost implant (day 1, weeks 16 and 32) with twice-daily topical timolol maleate 0.5%. An open-label, 24-month, phase 1/2 clinical trial compared one or two implants administered in the study eye with once-daily topical bimatoprost 0.03% in the fellow eye. Separate analyses of the pooled phase 3 and phase 1/2 study datasets evaluated outcomes in the 10-µg bimatoprost implant and comparator treatment arms after a single implant administration, up to the time of implant re-administration or rescue with IOP-lowering medication.
RESULTS
In the phase 3 studies, 10-µg bimatoprost implant single administration demonstrated IOP reductions (hour 0) of 4.9-7.0 mmHg through week 15 from a mean (standard deviation, SD) baseline IOP of 24.5 (2.6) mmHg (n = 374); IOP in the topical timolol BID group was reduced by 6.0-6.3 mmHg from a mean (SD) baseline IOP of 24.5 (2.6) mmHg (n = 373). In the phase 1/2 study (n = 21), median time to use of additional IOP-lowering treatment (Kaplan-Meier analysis) was 273 days (approximately 9 months), and 5 of 21 enrolled patients (23.8%) required no additional IOP-lowering treatment up to 24 months after single administration. In each study, after a single implant administration there were no reports of corneal edema, corneal endothelial cell loss, or corneal touch, and no patients had 20% or greater loss in corneal endothelial cell density.
CONCLUSIONS
Bimatoprost implant single administration lowers IOP and has a favorable safety profile. Additional studies are needed to further evaluate the duration of effect and factors predicting long-term IOP lowering after a single implant administration.
TRIAL REGISTRATION NUMBERS
ClinicalTrials.gov NCT02247804, NCT02250651, and NCT01157364.
引言
本研究评估了单次前房内注射10μg比马前列素植入剂对开角型青光眼或高眼压症成年患者的降眼压疗效和安全性。
方法
两项设计相同、随机、为期20个月的平行组3期临床试验（每例患者一只研究眼），将三次注射10μg或15μg比马前列素植入剂（第1天、第16周和第32周）与每日两次局部使用0.5%马来酸噻吗洛尔进行比较。一项开放标签、为期24个月的1/2期临床试验，将研究眼中注射一或两枚植入剂与对侧眼中每日一次局部使用0.03%比马前列素进行比较。对汇总的3期和1/2期研究数据集进行单独分析，评估单次植入比马前列素植入剂10μg治疗组和对照治疗组在再次植入或使用降眼压药物挽救之前的疗效。
结果
在3期研究中，单次注射10μg比马前列素植入剂，在第15周时眼压从平均（标准差，SD）基线眼压24.5（2.6）mmHg降低了4.9 - 7.0 mmHg（n = 374）；局部使用噻吗洛尔每日两次组的眼压从平均（SD）基线眼压24.5（2.6）mmHg降低了6.0 - 6.3 mmHg（n = 373）。在1/2期研究中（n = 21），使用额外降眼压治疗的中位时间（Kaplan-Meier分析）为273天（约9个月），21例入组患者中有5例（23.8%）在单次给药后24个月内无需额外的降眼压治疗。在每项研究中，单次植入给药后均未报告角膜水肿、角膜内皮细胞丢失或角膜触感问题，且没有患者角膜内皮细胞密度损失达20%或更多。
结论
单次注射比马前列素植入剂可降低眼压，且安全性良好。需要进一步研究以进一步评估单次植入给药后的疗效持续时间以及预测长期降眼压效果的因素。
试验注册号
ClinicalTrials.gov NCT02247804、NCT02250651和NCT01157364。
Zotero 插件