Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Ophthalmology. 2010 Nov;117(11):2146-51. doi: 10.1016/j.ophtha.2010.08.016. Epub 2010 Sep 19.
OBJECTIVES: To determine the long-term effects of ranibizumab (RBZ) in patients with diabetic macular edema (DME). DESIGN: Prospective, randomized, interventional, multicenter clinical trial. PARTICIPANTS: One hundred twenty-six patients with DME. METHODS: Subjects were randomized 1:1:1 to receive 0.5 mg RBZ at baseline and months 1, 3, and 5 (group 1), focal or grid laser photocoagulation at baseline and month 3 if needed (group 2), or a combination of 0.5 mg RBZ and focal or grid laser at baseline and month 3 (group 3). Starting at month 6, if retreatment criteria were met, all subjects could be treated with RBZ. MAIN OUTCOME MEASURES: The mean change from baseline in best-corrected visual acuity (BCVA) at month 24. RESULTS: After the primary end point at month 6, most patients in all groups were treated only with RBZ, and the mean number of injections was 5.3, 4.4, and 2.9 during the 18-month follow-up period in groups 1, 2, and 3, respectively. For the 33 patients in group 1, 34 patients in group 2, and 34 patients in group 3 who remained in the study through 24 months, the mean improvement in BCVA was 7.4, 0.5, and 3.8 letters at the 6-month primary end point, compared with 7.7, 5.1, and 6.8 letters at month 24, and the percentage of patients who gained 3 lines or more of BCVA was 21, 0, and 6 at month 6, compared with 24, 18, and 26 at month 24. The percentage of patients with 20/40 or better Snellen equivalent at month 24 was 45% in group 1, 44% in group 2, and 35% in group 3. Mean foveal thickness (FTH), defined as center subfield thickness, at month 24 was 340 μm, 286 μm, and 258 μm for groups 1, 2, and 3, respectively, and the percentage of patients with center subfield thickness of 250 μm or less was 36%, 47%, and 68%, respectively. CONCLUSIONS: Intraocular injections of RBZ provided benefit for patients with DME for at least 2 years, and when combined with focal or grid laser treatments, the amount of residual edema was reduced, as were the frequency of injections needed to control edema. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
目的：评估雷珠单抗（RBZ）治疗糖尿病黄斑水肿（DME）患者的长期疗效。
设计：前瞻性、随机、干预性、多中心临床试验。
参与者：126 例 DME 患者。
方法：患者按 1:1:1 比例随机分组，分别于基线时和第 1、3、5 个月给予 0.5mg RBZ（第 1 组）、基线时给予光凝治疗（若有需要，第 3 个月时再次给予），如果仍有需要则于第 3 个月时给予光凝治疗（第 2 组），或于基线时给予 RBZ 和光凝治疗（第 3 组）。自第 6 个月起，如果符合再治疗标准，则所有患者均可接受 RBZ 治疗。
主要观察指标：24 个月时最佳矫正视力（BCVA）自基线的平均变化值。
结果：在第 6 个月的主要终点后，各组大多数患者仅接受 RBZ 治疗，第 1、2、3 组患者在 18 个月的随访期间平均接受 RBZ 注射 5.3、4.4 和 2.9 次。第 1 组 33 例、第 2 组 34 例、第 3 组 34 例患者在 24 个月时仍在研究中，6 个月时 BCVA 的平均改善值分别为 7.4、0.5 和 3.8 个字母，而 24 个月时分别为 7.7、5.1 和 6.8 个字母，6 个月时视力提高 3 行或以上的患者比例分别为 21%、0%和 6%，而 24 个月时分别为 24%、18%和 26%。第 1、2、3 组患者在 24 个月时 20/40 或更好 Snellen 等效视力的比例分别为 45%、44%和 35%。24 个月时，各组患者的平均中心凹视网膜厚度（FTH）分别为 340μm、286μm 和 258μm，中心凹视网膜厚度 250μm 以下的患者比例分别为 36%、47%和 68%。
结论：雷珠单抗眼内注射治疗 DME 患者至少 2 年可获益，与光凝联合治疗时可减少残余水肿，且控制水肿所需的注射次数也减少。
金融披露：参考文献之后可能有专利或商业相关的披露。
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