Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration - Twelve-week results of an uncontrolled open-label clinical study
Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration - Twelve-week results of an uncontrolled open-label clinical study
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DOI：
10.1016/j.ophtha.2005.02.007
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发表时间：
2005-06-01
期刊：
影响因子：
13.7
通讯作者：
Venkatraman, AS
中科院分区：
文献类型：
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作者：
Michels, S;Rosenfeld, PJ;Venkatraman, AS
目的：评价贝伐单抗的短期安全性及其对新生血管性老年性黄斑变性(AMD)患者视力(VA)和中心凹下脉络膜新生血管(CNV)的影响。设计：开放、单中心、非对照临床研究。受试者：年龄相关性黄斑变性患者(N=9)，最佳矫正VA字母评分为70~20分(近似Snellen等效值，20/40-20/400)。方法：患者在基线水平接受贝伐单抗治疗(5 mg/kg)。然后每隔两周再加1或2剂。在所有访问中都进行了安全评估。眼科评估包括常规视力测量和眼部检查，以及光学相干断层扫描(OCT)成像、荧光素血管造影和吲哚青绿血管造影。主要结果测量：安全性评估，以及对VA评分、OCT测量和血管造影损害特征的变化进行评估。结果：未发现严重的眼部或全身不良事件。到6周时，唯一确定的不良事件是轻微的收缩压(BP)升高(+12毫米汞柱；P=0.035)，这种升高可以通过改变或开始服用抗高血压药物来控制。12周时，收缩压升高不再显著(P=0.51)。在研究眼中，治疗后1周内视力显著增加，到12周时，视力字母评分的中位数和平均分数分别增加了8个字母(P=0.011)和12个字母(P=0.008)。视网膜中央厚度中位数减少157µm(P=0.008)，平均减少177µm(P=0.001)。12周时，对侧眼VA字母的中位数和平均值分别增加了27个字母(P=0.018)和16个字母(P=0.012)，中心视网膜厚度分别减少了59微米(P=0.028)和92微米(P=0.06)。在所有研究眼，血管造影术显示CNV明显减少或无渗漏。结论：总体来说，贝伐单抗治疗耐受性良好，VA、OCT和血管造影术结果均有改善。尽管这些初步结果是有希望的，但在得出系统贝伐单抗治疗新生血管性AMD患者安全有效之前，有必要进行随机对照临床试验。
Purpose: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD).Design: Open-label, single-center, uncontrolled clinical study.Participants: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400).Methods: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography.Main Outcome Measurements: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics.Results: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+ 12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating anti hypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 mu m (P = 0.008) and 177 mu m (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 mu m (P = 0.028) and 92 mu m (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV.Conclusion: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD.