Larsen Michael, Waldstein Sebastian M, Priglinger Siegfried, Hykin Philip, Barnes Elizabeth, Gekkieva Margarita, Das Gupta Ayan, Wenzel Andreas, Monés Jordi
Department of Ophthalmology, Rigshospitalet and Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Ophthalmology, Vienna Reading Center, Medical University of Vienna, Vienna, Austria.
Ophthalmol Retina. 2018 Feb;2(2):134-142. doi: 10.1016/j.oret.2017.05.016. Epub 2017 Sep 9.
To assess the efficacy and safety profile of an individualized, stabilization criteria-driven regimen of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
A 24-month, prospective, open-label, single-arm, multicenter study.
A total of 357 patients.
Patients received monthly ranibizumab 0.5 mg injections (minimum, 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg injections were administered if monitoring indicated a loss of VA due to disease activity. The primary outcome results have been published previously.
Mean change from baseline at months 1 through 24 in best-corrected VA (BCVA) in the overall population and in subgroups categorized according to baseline BCVA, CRVO duration, or presence of macular ischemia.
The baseline mean BCVA was 53.0 letters and baseline mean CRVO duration was 8.9 months (median, 2.4 months). The mean (standard deviation) gain in BCVA from baseline with ranibizumab 0.5 mg at month 24 was 12.1 (18.60) letters (P < 0.0001). Best-corrected VA gains at month 24 were similar in patients with or without baseline macular ischemia (mean change, 11.1 and 12.9 letters, respectively). The mean BCVA gain at month 24 was higher in patients with CRVO duration <3 months (13.2 letters) compared with that in those with CRVO duration >9 months (10.5 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 24 (≤39 letters; 18.5 letters) than those with higher baseline BCVA (40-59/≥60 letters; 13.9/7.2 letters), although the absolute BCVA values at month 24 were higher in patients with higher baseline BCVA. The mean (standard deviation) and median number of ranibizumab injections up to month 23 were 13.1 (6.39) and 15.0 injections, respectively. No new ocular or nonocular safety events were reported.
An individualized, stabilization criteria-driven dosing regimen of ranibizumab 0.5 mg led to sustained BCVA gains for up to 24 months in patients with CRVO. The presence of macular ischemia at baseline did not influence VA gains. Shorter duration of CRVO at baseline was associated with better VA gains. Safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.
评估采用个性化、基于稳定标准的0.5毫克雷珠单抗治疗方案，对因视网膜中央静脉阻塞（CRVO）继发黄斑水肿导致视力损害患者的疗效和安全性。
一项为期24个月的前瞻性、开放标签、单臂、多中心研究。
共357例患者。
患者每月接受0.5毫克雷珠单抗注射（最少3次注射），直至连续3个月维持稳定视力（VA）。此后，如果监测显示因疾病活动导致视力下降，则给予0.5毫克雷珠单抗注射。主要结局结果已在之前发表。
总体人群以及根据基线最佳矫正视力（BCVA）、CRVO病程或黄斑缺血情况分类的亚组中，第1至24个月时最佳矫正视力相对于基线的平均变化。
基线时平均BCVA为53.0个字母，基线时CRVO平均病程为8.9个月（中位数为2.4个月）。第24个月时，0.5毫克雷珠单抗治疗组相对于基线的BCVA平均（标准差）提高了12.1（18.60）个字母（P<0.0001）。基线时有或无黄斑缺血的患者在第24个月时最佳矫正视力提高情况相似（平均变化分别为11.1和12.9个字母）。CRVO病程<3个月的患者在第24个月时的平均BCVA提高幅度（13.2个字母）高于CRVO病程>9个月的患者（10.5个字母）。基线BCVA较低的患者在第24个月时平均BCVA提高幅度（≤39个字母；18.5个字母）大于基线BCVA较高的患者（40 - 59/≥60个字母；13.9/7.2个字母），尽管基线BCVA较高的患者在第24个月时的绝对BCVA值更高。截至第23个月，雷珠单抗注射的平均（标准差）次数和中位数分别为13.1（6.39）次和15.0次。未报告新的眼部或非眼部安全事件。
采用个性化、基于稳定标准的0.5毫克雷珠单抗给药方案，可使CRVO患者的BCVA持续提高长达24个月。基线时黄斑缺血的存在不影响视力提高。基线时CRVO病程较短与更好的视力提高相关。安全性结果与之前雷珠单抗治疗CRVO患者的研究报告一致。
