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雷珠单抗联合或不联合激光治疗视网膜分支静脉阻塞的持续益处:BRIGHTER研究的24个月结果

Tadayoni, R., Waldstein, S.M., Boscia, F., et al.

期刊名称:Ophthalmology

卷期:2017年第124卷第12期

摘要

摘要:目的:旨在使用个体视力(VA)稳定标准评估雷珠单抗0.5 mg有或无激光治疗对视力障碍患者的长期(24个月)疗效和安全性。设计:IIIb期,开放标记,随机,主动对照,3组,多中心研究。研究对象:共455例患者。方法:患者随机分组(221)接受雷珠单抗0.5mgn = 183),(雷珠单抗0.5mg加激光(n=180)或激光(6个月后可选雷珠单抗0.5mg n = 92)。在最初3次每月注射之后,雷珠单抗患者(有或者没有激光治疗组)接受VA稳定标准PRN治疗。激光治疗组患者根据研究人员考虑接受激光治疗。主要观察指标:从基线至第24月的最佳矫正视力(BCVA)和中心子区厚度(CSFT)的平均变化,以及24个月以上的安全性。结果:380例患者(83.5%)完成了研究。雷珠单抗联合或不联合激光治疗组的BCVA均优于激光治疗组(6个月起单药治疗与雷珠单抗联合治疗;17.3 / 15.511.6个字母; P <0.0001)。雷珠单抗联合激光治疗优于雷珠单抗单药治疗(平均BCVA改变:15.415.0; P <0.0001)。然而,加入激光不能减少雷珠单抗注射次数(平均注射:11.411.3; P = 0.4259)。从基线起24个月内,雷珠单抗联合或不联合激光治疗组的CSFT均有较大下降(雷珠单抗单药治疗224.7μm,雷珠单抗联合激光248.9μm6个月起激光联合雷珠单抗治疗197.5μm)。黄斑局部缺血不影响BCVA结果或治疗频次。没有关于新生血管性青光眼或虹膜新血管形成的报道。没有发现新的安全性信号。结论:BRIGHTER研究结果证实了个体化VA稳定标准下使用雷珠单抗0.5 mg PRN剂量治疗BRVO患者的长期疗效和安全性。激光治疗不会带来更好的功能预后或较低的治疗需求。安全性结果与已确定的雷珠单抗的安全性一致。

PURPOSE:To evaluate the long-term (24-month) efficacy and safety of ranibizumab 0.5 mg administered pro re nata (PRN) with or without laser using an individualized visual acuity (VA) stabilization criteria in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO).DESIGN:Phase IIIb, open-label, randomized, active-controlled, 3-arm, multicenter study.PARTICIPANTS:A total of 455 patients.METHODS:Patients were randomized (2:2:1) to ranibizumab 0.5 mg (n= 183), ranibizumab 0.5 mg with laser (n= 180), or laser (with optional ranibizumab 0.5 mg after month 6; n= 92). After initial 3 monthly injections, patients in the ranibizumab with or without laser arms received VA stabilization criteria-driven PRN treatment. Patients assigned to the laser arm received laser at the investigator's discretion.MAIN OUTCOME MEASURES:Mean (and mean average) change in best-corrected visual acuity (BCVA) and central subfield thickness (CSFT) from baseline to month 24, and safety over 24 months.RESULTS:A total of 380 patients (83.5%) completed the study. Ranibizumab with or without laser led to superior BCVA outcomes versus laser (monotherapy and combined with ranibizumab from month 6; 17.3/15.5 vs. 11.6 letters; P < 0.0001). Ranibizumab with laser was noninferior to ranibizumab monotherapy (mean average BCVA change: 15.4 vs. 15.0 letters; P < 0.0001). However, addition of laser did not reduce the number of ranibizumab injections (mean injections: 11.4 vs. 11.3; P= 0.4259). A greater reduction in CSFT was seen with ranibizumab with or without laser versus laser monotherapy over 24 months from baseline (ranibizumab monotherapy-224.7 μm, ranibizumab with laser-248.9 μm, laser [monotherapy and combined with ranibizumab from month 6]-197.5 μm). Presence of macular ischemia did not affect BCVA outcome or treatment frequency. There were no reports of neovascular glaucoma or iris neovascularization. No new safety signals were identified.CONCLUSIONS:The BRIGHTER study results confirmed the long-term efficacy and safety profile of PRN dosing driven by individualized VA stabilization criteria using ranibizumab 0.5 mg in patients with BRVO. Addition of laser did not lead to better functional outcomes or lower treatment need. The safety results were consistent with the well-established safety profile of ranibizumab.


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