The Wilmer Eye Institute, Department of Ophthalmology and Neuroscience, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA.
Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.
To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO).
Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
A total of 397 patients with macular edema following BRVO.
Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections.
The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT).
Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P<0.0001 for each ranibizumab group vs sham). The percentage of patients who gained > or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P<0.0001 for each ranibizumab group vs sham). At month 6, significantly more ranibizumab-treated patients (0.3 mg, 67.9%; 0.5 mg, 64.9%) had BCVA of > or =20/40 compared with sham patients (41.7%; P<0.0001 for each ranibizumab group vs sham); and CFT had decreased by a mean of 337 microm (0.3 mg) and 345 microm (0.5 mg) in the ranibizumab groups and 158 microm in the sham group (P<0.0001 for each ranibizumab group vs sham). The median percent reduction in excess foveal thickness at month 6 was 97.0% and 97.6% in 0.3 mg and 0.5 mg groups and 27.9% in the sham group. More patients in the sham group (54.5%) received rescue grid laser compared with the 0.3 mg (18.7%) and 0.5 mg (19.8%) ranibizumab groups. The safety profile was consistent with previous phase III ranibizumab trials, and no new safety events were identified in patients with BRVO.
Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid, effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events.
评估玻璃体内注射 0.3mg 或 0.5mg 雷珠单抗治疗视网膜分支静脉阻塞（BRVO）后黄斑水肿的疗效和安全性。
前瞻性、随机、假注射对照、双盲、多中心临床试验。
共 397 例 BRVO 后黄斑水肿患者。
符合条件的患者以 1:1:1 的比例随机分为 3 组，分别接受每月玻璃体内注射 0.3mg 或 0.5mg 雷珠单抗或假注射。
主要疗效观察指标为第 6 个月时最佳矫正视力（BCVA）字母评分的平均变化。次要结局包括其他视觉功能参数和中心视网膜厚度（CFT）。
第 6 个月时，0.3mg 和 0.5mg 雷珠单抗组 BCVA 字母评分的平均（95%置信区间[CI]）变化分别为 16.6（14.7-18.5）和 18.3（16.0-20.6），假注射组为 7.3（5.1-9.5）（各组与假注射组相比，P<0.0001）。第 6 个月时，BCVA 提高≥15 个字母的患者比例分别为 55.2%（0.3mg）和 61.1%（0.5mg），假注射组为 28.8%（各组与假注射组相比，P<0.0001）。第 6 个月时，与假注射组相比，更多雷珠单抗治疗组（0.3mg，67.9%；0.5mg，64.9%）的患者 BCVA>或=20/40（P<0.0001），且 CFT 平均减少 337μm（0.3mg）和 345μm（0.5mg），假注射组减少 158μm（各组与假注射组相比，P<0.0001）。第 6 个月时，0.3mg 和 0.5mg 组多余黄斑厚度的中位百分比降低分别为 97.0%和 97.6%，假注射组为 27.9%。与 0.3mg（18.7%）和 0.5mg（19.8%）雷珠单抗组相比，更多假注射组患者（54.5%）接受了格栅激光治疗。安全性特征与之前的雷珠单抗 III 期试验一致，BRVO 患者未发现新的安全性事件。
玻璃体内注射 0.3mg 或 0.5mg 雷珠单抗可快速有效治疗 BRVO 后黄斑水肿，眼部和非眼部安全性事件发生率低。
