Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study
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DOI：
10.1016/j.ophtha.2009.04.023
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发表时间：
2009-11-01
期刊：
影响因子：
13.7
通讯作者：
Campochiaro, Peter A.
中科院分区：
文献类型：
--
作者：
Nguyen, Quan Dong;Shah, Syed Mahmood;Campochiaro, Peter A.
目的：比较雷珠单抗与焦点/网格激光或两者联合治疗糖尿病性黄斑水肿 (DME)。设计：前瞻性、随机、介入、多中心临床试验。参与者：总共 126 名 DME 患者。方法：受试者按 1:1:1 随机分配，在基线和第 1、3 和 5 个月接受 0.5 mg 雷珠单抗（第 1 组，42 名患者），焦点/网格激光如果需要，在基线和第 3 个月进行光凝治疗（第 2 组，42 名患者），或在基线和第 3 个月联合使用 0.5 mg 雷珠单抗和聚焦/网格激光（第 3 组，42 名患者）。主要结果指标：主要终点是第 6 个月时最佳矫正视力 (BCVA) 较基线的变化。结果：第 6 个月时，第 1 组的 BCVA 平均增益显着更高（+7.24 个字母，P = 0.01，方差分析）与第 2 组（-0.43 个字母）相比，第 3 组（+3.80 个字母）与第 1 组或第 2 组没有统计学差异。对于 6 个月时可获得数据的患者，第 1 组 37 例中有 8 例（22%）出现 3 行或更多改善，而第 2 组 38 例中有 0 例（0%）出现 3 行或更多改善（P = 0.002， Fisher 精确检验）和第 3 组中的 40 个中的 3 个（8%）。第 1、2 和 3 组中的中心凹厚度分别减少了 50%、33% 和 45%。结论：在 6 个月的时间里，DME 患者中，按照当前方案注射雷珠单抗比聚焦/网格激光治疗具有显着更好的视觉结果。 财务披露：可能会发现专有或商业披露参考文献之后。眼科 2009；116:2175-2181 (C) 2009 年，美国眼科学会。
Objectives: To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).Design: Prospective, randomized, interventional, multicenter clinical trial.Participants: A total of 126 patients with DME.Methods: Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).Main Outcome Measures: The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.Results: At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.Conclusions: During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2009;116:2175-2181 (C) 2009 by the American Academy of Ophthalmology.