A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema
A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema
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DOI：
10.1016/j.ophtha.2006.04.033
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发表时间：
2006-10-01
期刊：
影响因子：
13.7
通讯作者：
Bankert, Joy M.
中科院分区：
文献类型：
--
作者：
Chun, Dal W.;Heier, Jeffrey S.;Bankert, Joy M.
目的：评价雷珠单抗多次玻璃体内注射治疗有临床意义的糖尿病黄斑水肿（DME）患者的生物学活性，并报告任何相关的不良事件。设计：单中心，开放标签，剂量递增的初步研究。10例患者共10只眼（平均年龄，69.3岁[范围，59-81]），DME累及黄斑中心，研究眼的最佳矫正视力（BCVA）在20/63和20/400之间。在第0天、第1个月和第2个月进行三次玻璃体内注射雷珠单抗（每次0.3 mg或0.5 mg），并观察至第24个月。主要结果测量：主要终点是眼部和全身不良事件的频率和严重程度。次要终点是最佳矫正视力和视网膜厚度的光学相干断层扫描测量。结果：10例患者入组，5人接受0.3毫克和5人接受0.5毫克雷珠单抗。玻璃体内注射雷珠单抗耐受性良好。未报告全身不良事件。报告了5例轻度至中度眼部炎症。在第3个月，10名患者中有4名获得>= 15个字母，10名患者中有5名获得>= 10个字母，10名患者中有8名获得>= 1个字母。在第3个月，平均减少视网膜厚度的中心点的中央子场为45.3 +/- 196.3 μ m的低剂量组和197.8 +/- 85.9 μ m的高剂量group.Conclusions：兰尼单抗似乎是一种耐受性良好的治疗DME患者。这项初步研究表明，雷珠单抗治疗有可能维持或改善BCVA并降低中心累及临床显着DME患者的视网膜厚度。
Objective: To evaluate the biologic activity of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema (DME) and to report any associated adverse events.Design: Single-center, open-label, dose-escalating pilot study.Participants: A total of 10 eyes of 10 patients (mean age, 69.3 years [range, 59-81]) with DME involving the center of the macula and best-corrected visual acuity (BCVA) in the study eye between 20/63 and 20/400.Intervention: Three intravitreal injections of ranibizumab (0.3 mg or 0.5 mg each injection) administered on day 0, month 1, and month 2, and observation until month 24.Main Outcome Measures: Primary end points were the frequency and severity of ocular and systemic adverse events. Secondary end points were BCVA and measurement of retinal thickness by optical coherence tomography.Results: Of the 10 patients enrolled, 5 received 0.3-mg and 5 received 0.5-mg ranibizumab. Intravitreal injections of ranibizumab were well tolerated. No systemic adverse events were reported. Five occurrences of mild to moderate ocular inflammation were reported. At month 3, 4 of 10 patients gained >= 15 letters, 5 of 10 gained >= 10 letters, and 8 of 10 gained >= 1 letters. At month 3, the mean decrease in retinal thickness of the center point of the central subfield was 45.3 +/- 196.3 mu m for the low-dose group and 197.8 +/- 85.9 mu m for the high-dose group.Conclusions: Ranibizumab appears to be a well-tolerated therapy for patients with DME. This pilot study demonstrates that ranibizumab therapy has the potential to maintain or improve BCVA and reduce retinal thickness in patients with center-involved clinically significant DME.