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标题:雷珠单抗联合或不联合维替泊芬光动力治疗息肉样脉络膜血管病变的疗效和安全性:一项随机临床试验

Koh, A., TYY, L., Takahashi, K., et al.

期刊名称:JAMA Ophthalmology

卷期:2017年第135卷第11期

摘要

摘要:重要性:息肉样脉络膜血管病变(PCV)是亚洲人渗出性年龄相关性黄斑变性的常见亚型。据我们所知,目前还没有大规模的随机临床试验来评估玻璃体内注射雷珠单抗(有和无维替泊芬光动力治疗(vPDT))治疗PCV的疗效。目的:旨在比较雷珠单抗联合vPDT治疗与雷珠单抗单药治疗PCV的疗效和安全性。设计,设置,和研究对象:201387日至201732日进行了一项双盲多中心随机临床试验,其中有322例由中央阅读中心使用吲哚菁绿血管造影证实的有症状黄斑PCV患者。干预:参与者随机11分为雷珠单抗0.5mgvPDTn = 168;联合治疗组)或雷珠单抗0.5mg单药,和假PDTn = 154;单一治疗组)治疗。所有参与者均连续3个月接受雷珠单抗注射,随后接受按需治疗方案(pro re nata)治疗。参与者还在第1天接受了vPDT / 假性PDT,接着根据活性息肉损害情况进行了按需治疗方案治疗。主要预后指标:第1步评估与基线相比,联合治疗的最佳矫正视力是否不劣于(5个字母边缘)单药治疗变化,并在完全息肉消退方面是否表现优异。如果确立了非劣效性,则第2步评估在第12月时联合治疗的最佳矫正视力变化是否优于单一疗法。结果:治疗组之间的322名参与者的基线人口统计学可比较。平均(SD)年龄为68.18.8)岁,总体而言,69.9%患者为男性。基线时,整体平均最佳矫正视力和平均中心子区厚度分别为61.1字母和413.3μm。在12个月时,与基线相比,联合治疗平均改善8.3个字母,单一治疗平均改善5.1个字母(平均差3.2个字母; 95CI 0.4-6.1),表明联合治疗符合非劣效性的预定义标准,且优于单药治疗(P = 0.01)。在实现完全息肉消退方面,12个月时联合治疗也优于单一疗法(69.3%: 34.7; P <0.001)。联合治疗组在12个月内接受雷珠单抗注射中位数为4.0,而单药治疗组为7.0。玻璃体积血是唯一严重的不良事件(联合治疗组,1 [0.6];单药治疗组,3 [2.0])。结论和相关性:12个月后,雷珠单抗加vPDT联合治疗不但不劣于雷珠单抗,而且在最佳矫正视力和完全息肉消退方面优于单用雷珠单抗,且需要较少的注射次数。 PCV眼应考虑联合治疗。试验注册:clinicaltrials.gov标识符:NCT01846273

Importance:Polypoidal choroidal vasculopathy (PCV) is a common subtype of exudative age-related macular degeneration among Asian individuals. To our knowledge, there are no large randomized clinical trials to evaluate intravitreal ranibizumab, with and without verteporfin photodynamic therapy (vPDT), for the treatment of PCV.Objective:To compare the efficacy and safety of combination therapy of ranibizumab and vPDT with ranibizumab monotherapy in PCV.Design, Setting, and Participants:A double-masked, multicenter randomized clinical trial of 322 Asian participants with symptomatic macular PCV confirmed by the Central Reading Center using indocyanine green angiography was conducted between August 7, 2013, and March 2, 2017.Interventions:Participants were randomized 1:1 to ranibizumab, 0.5 mg, and vPDT (n=168; combination therapy group) or ranibizumab, 0.5 mg, and sham PDT (n=154; monotherapy group). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT/sham PDT on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.Main Outcomes and Measures:Step 1 assessed whether combination therapy was noninferior (5-letter margin) to monotherapy for change in best-corrected visual acuity from baseline and superior in complete polyp regression. If noninferiority was established, step 2 assessed whether combination therapy was superior to monotherapy measured by best-corrected visual acuity change at month 12.Results:Baseline demographics of the 322 participants were comparable between the treatment groups. Mean (SD) age of the patients was 68.1 (8.8) years, and overall, 69.9% of the patients were men. At baseline, the overall mean best-corrected visual acuity and mean central subfield thickness were 61.1 letters and 413.3 μm, respectively. At 12 months, mean improvement from baseline was 8.3 letters with combination therapy vs 5.1 letters with monotherapy (mean difference, 3.2 letters; 95% CI, 0.4-6.1), indicating that combination therapy met the predefined criterion for noninferiority as well as being superior to monotherapy (P=.01). Combination therapy was also superior to monotherapy in achieving complete polyp regression at month 12 (69.3% vs 34.7%; P<.001). Over 12 months, the combination therapy group received a median of 4.0 ranibizumab injections compared with 7.0 in the monotherapy group. Vitreous hemorrhage was the only ocular serious adverse event (combination therapy group, 1 [0.6%]; monotherapy group, 3 [2.0%]).Conclusions and Relevance:After 12 months, combination therapy of ranibizumab plus vPDT was not only noninferior but also superior to ranibizumab monotherapy in best-corrected visual acuity and superior in complete polyp regression while requiring fewer injections. Combination therapy should be considered for eyes with PCV.Trial Registration:clinicaltrials.gov Identifier: NCT01846273.


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