Sustained Benefits from Ranibizumab for Macular Edema Following Branch Retinal Vein Occlusion: 12-Month Outcomes of a Phase III Study
Sustained Benefits from Ranibizumab for Macular Edema Following Branch Retinal Vein Occlusion: 12-Month Outcomes of a Phase III Study
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DOI：
10.1016/j.ophtha.2011.02.022
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发表时间：
2011-08-01
期刊：
影响因子：
13.7
通讯作者：
Murahashi, Wendy Yee
中科院分区：
文献类型：
--
作者：
Brown, David M.;Campochiaro, Peter A.;Murahashi, Wendy Yee
目的：评估眼内注射0.3 mg或0.5 mg雷珠单抗治疗视网膜分支静脉阻塞（BRVO）后黄斑水肿患者12个月的疗效和安全性。设计：前瞻性、随机、假注射对照、双盲、多中心试验。参与者：共397例BRVO后黄斑水肿患者。方法：合格患者按1：1随机分组：1至6个月注射0.3 mg或0.5 mg雷珠单抗或假注射。6个月后，所有研究眼最佳矫正视力（BCVA）= 250 μ m的患者均接受雷珠单抗治疗。如果符合标准，患者可以在治疗期间接受一次补救激光治疗，并在观察期间接受一次补救激光治疗。主要结果测量：报告的主要疗效结果是第12个月时BCVA字母评分较基线的平均变化。其他视觉和解剖参数进行了评估。是说（95%置信区间）第12个月BCVA字母评分较基线的变化为16.4（14.5-18.4）和18.3 0.3 mg和0.5 mg组分别为（15.8 - 20.9），（9.6-14.6）（P < 0.01，每个雷珠单抗组与假手术/0.5 mg）。0.3 mg和0.5 mg组第12个月BCVA较基线增加≥ 15个字母的患者百分比分别为56.0%和60.3%，假手术/0.5 mg组为43.9%。平均而言，在假手术/0.5 mg组中首次按需注射0.5 mg雷珠单抗后，中央凹厚度（CFT）显著降低，并持续至第12个月。没有新的眼部或非眼部安全事件被identified.Conclusions：在第12个月，治疗与雷珠单抗需要在6-11个月保持，平均而言，所取得的好处，6个月雷珠单抗注射黄斑水肿后BRVO患者，与眼部和非眼部安全事件的低利率。在假手术/0.5 mg组中，根据需要用雷珠单抗治疗6个月导致CFT快速降低至与0.3 mg雷珠单抗治疗组相似的水平，BCVA改善，但没有达到2个雷珠单抗组的程度。眼内注射雷珠单抗可有效治疗BRVO后黄斑水肿。财务披露：专利或商业披露可在参考文献后找到。Ophthalmology 2011; 118：1594-1602（C）2011，美国眼科学会。
Purpose: Assess 12-month efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after branch retinal vein occlusion (BRVO).Design: Prospective, randomized, sham injection-controlled, double-masked, multicenter trial.Participants: A total of 397 patients with macular edema after BRVO.Methods: Eligible patients were randomized 1: 1: 1 to 6 monthly injections of 0.3 mg or 0.5 mg ranibizumab or sham injections. After 6 months, all patients with study eye best-corrected visual acuity (BCVA) = 250 mu m were to receive ranibizumab. Patients could receive rescue laser treatment once during the treatment period and once during the observation period if criteria were met. Main Outcome Measures: The main efficacy outcome reported is mean change from baseline BCVA letter score at month 12. Additional visual and anatomic parameters were assessed.Results: Mean (95% confidence interval) change from baseline BCVA letter score at month 12 was 16.4 (14.5-18.4) and 18.3 (15.8 -20.9) in the 0.3 mg and 0.5 mg groups, respectively, and 12.1 (9.6-14.6) in the sham/0.5 mg group (P < 0.01, each ranibizumab group vs. sham/0.5 mg). The percentage of patients who gained >= 15 letters from baseline BCVA at month 12 was 56.0% and 60.3% in the 0.3 mg and 0.5 mg groups, respectively, and 43.9% in the sham/0.5 mg group. On average, there was a marked reduction in central foveal thickness (CFT) after the first as-needed injection of 0.5 mg ranibizumab in the sham/0.5 mg group, which was sustained through month 12. No new ocular or nonocular safety events were identified.Conclusions: At month 12, treatment with ranibizumab as needed during months 6-11 maintained, on average, the benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after BRVO, with low rates of ocular and nonocular safety events. In the sham/0.5 mg group, treatment with ranibizumab as needed for 6 months resulted in rapid reduction in CFT to a similar level as that in the 0.3 mg ranibizumab treatment group and an improvement in BCVA, but not to the extent of that in the 2 ranibizumab groups. Intraocular injections of ranibizumab provide an effective treatment for macular edema after BRVO.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2011; 118: 1594-1602 (C) 2011 by the American Academy of Ophthalmology.