EVEREST STUDY Efficacy and Safety of Verteporfin Photodynamic Therapy in Combination with Ranibizumab or Alone Versus Ranibizumab Monotherapy in Patients with Symptomatic Macular Polypoidal Choroidal Vasculopathy
EVEREST STUDY Efficacy and Safety of Verteporfin Photodynamic Therapy in Combination with Ranibizumab or Alone Versus Ranibizumab Monotherapy in Patients with Symptomatic Macular Polypoidal Choroidal Vasculopathy
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DOI：
10.1097/iae.0b013e31824f91e8
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发表时间：
2012-09-01
影响因子：
3.3
通讯作者：
Lim, Tock H.
中科院分区：
文献类型：
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作者：
Koh, Adrian;Lee, Won Ki;Lim, Tock H.
目的：评估维替泊芬光动力疗法（PDT）联合雷珠单抗或单独与雷珠单抗单药治疗有症状的黄斑息肉状脉络膜vasculopathy.Methods：在这个多中心，双盲，主要是吲哚菁绿色血管造影引导的试验，61例亚洲患者随机维替泊芬PDT（标准通量），雷珠单抗0.5毫克，或组合的影响。患者给予维替泊芬PDT/安慰剂，并从第1天开始连续3个月接受雷珠单抗/假注射，并根据预定标准重新治疗（第3-5个月）。主要终点是第6个月时吲哚菁绿色血管造影评估息肉完全消退的患者比例。次要终点包括6个月时最佳矫正视力的平均变化和安全性。结果：6个月时，维替泊芬联合雷珠单抗或单独使用在实现息肉完全消退方面优于雷珠单抗单药治疗上级（77.8%和71.4%对28.6%;P < 0.01）;最佳矫正视力（字母）的平均变化+/-标准差为10.9 +/- 10.9（维替泊芬PDT +雷珠单抗）、7.5 +/-10.6（维替泊芬PDT）和9.2 +/-12.4（雷珠单抗）。有没有新的安全性结果，无论是单独使用药物或combined.Conclusion：维替泊芬PDT联合雷珠单抗0.5毫克或单独雷珠单抗单药治疗是上级在这个6个月的研究中，在症状性黄斑息肉状脉络膜血管病变的患者实现息肉完全消退。所有治疗在6个月内耐受良好。
Purpose: To assess the effects of verteporfin photodynamic therapy (PDT) combined with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy.Methods: In this multicenter, double-masked, primarily indocyanine green angiography-guided trial, 61 Asian patients were randomized to verteporfin PDT (standard fluence), ranibizumab 0.5 mg, or the combination. Patients were administered with verteporfin PDT/placebo and initiated with three consecutive monthly ranibizumab/sham injections starting Day 1, and re-treated (Months 3-5) as per predefined criteria. The primary endpoint was the proportion of patients with indocyanine green angiography-assessed complete regression of polyps at Month 6. Secondary endpoints included mean change in best-corrected visual acuity at Month 6 and safety.Results: At Month 6, verteporfin combined with ranibizumab or alone was superior to ranibizumab monotherapy in achieving complete polyp regression (77.8% and 71.4% vs. 28.6%;P < 0.01); mean change +/- standard deviation in best-corrected visual acuity (letters) was 10.9 +/- 10.9 (verteporfin PDT + ranibizumab), 7.5 +/- 10.6 (verteporfin PDT), and 9.2 +/- 12.4 (ranibizumab). There were no new safety findings with either drug used alone or in combination.Conclusion: Verteporfin PDT combined with ranibizumab 0.5 mg or alone was superior to ranibizumab monotherapy in achieving complete regression of polyps in this 6-month study in patients with symptomatic macular polypoidal choroidal vasculopathy. All treatments were well tolerated over 6 months.