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.
Ophthalmology. 2016 May;123(5):1101-11. doi: 10.1016/j.ophtha.2016.01.011. Epub 2016 Feb 17.
To assess the 12-month efficacy and safety profile of an individualized regimen of ranibizumab 0.5 mg driven by stabilization criteria in patients with macular edema secondary to central retinal vein occlusion (CRVO).
A 24-month, prospective, open-label, single-arm, multicenter study.
Three hundred fifty-seven patients.
Patients were treated with monthly ranibizumab 0.5-mg injections (minimum of 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg was dosed as needed if monthly monitoring indicated a loss of VA resulting from disease activity.
Mean change from baseline at month 12 in best-corrected VA (BCVA; primary end point) and safety over 12 months. The efficacy of this regimen in subgroups categorized by baseline BCVA score, CRVO duration, or presence of macular ischemia (exploratory analysis).
At baseline, the mean BCVA was 53.0 letters and mean CRVO duration was 8.9 months (median, 2.4 months). Ranibizumab 0.5-mg treatment resulted in a statistically significant mean gain in BCVA from baseline at month 12 of 12.3 letters (standard deviation [SD], 16.72 letters; P < 0.0001). The mean number of ranibizumab injections up to month 12 was 8.1 (SD, 2.77). At month 12, mean BCVA gains were similar with or without macular ischemia at baseline (11.6 vs. 12.1 letters); the mean BCVA gain was higher with baseline CRVO duration of less than 3 months (13.4 letters) than with a longer duration (≥3-<9 months, 11.1 letters; ≥9 months, 10.9 letters). Patients with lower baseline BCVA had larger mean BCVA gains at month 12 than those with higher baseline BCVA (≤39/40-59/≥60 and 18.0/12.7/8.9 letters, respectively), although the absolute BCVA at month 12 was higher with higher baseline BCVA. No new ocular or nonocular safety events were observed.
An individualized dosing regimen of ranibizumab 0.5 mg driven by stabilization criteria for up to 12 months resulted in significant BCVA gain in a broad population of patients with macular edema secondary to CRVO, including those with macular ischemia at baseline. The safety findings were consistent with those reported in previous ranibizumab studies in patients with CRVO.
评估在因中央视网膜静脉阻塞（CRVO）而导致的黄斑水肿患者中，根据稳定标准制定的个体化雷珠单抗 0.5mg 方案治疗 12 个月的疗效和安全性。
一项为期 24 个月、前瞻性、开放标签、单臂、多中心研究。
357 例患者。
患者每月接受雷珠单抗 0.5mg 注射（最少 3 次），直至连续 3 个月保持稳定的最佳矫正视力（BCVA）。此后，如果每月监测发现疾病活动导致视力丧失，则按需给予雷珠单抗 0.5mg。
在第 12 个月时，从基线开始的 BCVA（主要终点）的平均变化以及 12 个月的安全性。该方案在根据基线 BCVA 评分、CRVO 持续时间或黄斑缺血情况进行分类的亚组中的疗效（探索性分析）。
基线时，平均 BCVA 为 53.0 个字母，CRVO 持续时间平均为 8.9 个月（中位数为 2.4 个月）。雷珠单抗 0.5mg 治疗在第 12 个月时从基线开始的平均 BCVA 提高了 12.3 个字母（标准差为 16.72 个字母；P<0.0001）。截至第 12 个月，雷珠单抗注射的平均次数为 8.1（标准差为 2.77）。第 12 个月时，有或没有基线黄斑缺血的患者平均 BCVA 提高相似（11.6 与 12.1 个字母）；基线 CRVO 持续时间小于 3 个月的患者平均 BCVA 提高较高（13.4 个字母），而持续时间较长的患者（≥3-<9 个月，11.1 个字母；≥9 个月，10.9 个字母）。基线 BCVA 较低的患者在第 12 个月时的平均 BCVA 提高大于基线 BCVA 较高的患者（分别为≤39/40-59/≥60 和 18.0/12.7/8.9 个字母），尽管第 12 个月时的绝对 BCVA 更高。没有观察到新的眼部或非眼部安全性事件。
在因 CRVO 导致的黄斑水肿患者中，根据稳定标准制定的个体化雷珠单抗 0.5mg 剂量方案最长可达 12 个月，可显著提高 BCVA，包括基线时有黄斑缺血的患者。安全性发现与先前雷珠单抗治疗 CRVO 患者的研究结果一致。
