Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.
Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.
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抗血管内皮生长因子比较有效性试验的糖尿病性黄斑水肿：一项随机临床试验的事后分析后的其他功效。
DOI：
10.1001/jamaophthalmol.2016.3698
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发表时间：
2016-12-01
影响因子：
8.1
通讯作者：
Diabetic Retinopathy Clinical Research Network
中科院分区：
文献类型：
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作者：
Jampol LM;Glassman AR;Bressler NM;Wells JA;Ayala AR;Diabetic Retinopathy Clinical Research Network
DRCR.net 随机试验比较阿柏西普、贝伐珠单抗和雷珠单抗治疗糖尿病性黄斑水肿 (DME) 的事后分析可能会影响研究结果的解释。为了提供额外的事后临床相关结果，比较三种抗 VEGF 药物用于 DME 事后分析来自一项 660 名参与者的 2 年随机临床试验，比较了三种抗 VEGF 治疗对导致视力损害的中心参与的 DME 的眼睛。根据结构化再治疗方案，随机分配至玻璃体内注射阿柏西普 (2.0 mg)、贝伐单抗 (1.25 mg) 或雷珠单抗 (0.3 mg)，最多每月一次。 6 个月后添加焦点/网格激光以治疗持续性 DME。曲线下视力区域的变化；根据研究期间眼睛是否接受 DME 激光治疗，亚组内中心亚视野厚度 (CST) 的变化 对于初始视力 (VA) 20/50 或更差的眼睛，阿柏西普在一年时的 VA 改善大于其他药物，但在两年访视时仅优于贝伐珠单抗。 VA 在一到两年内基本保持稳定（阿柏西普：-1.2 个字母 [P=0.24]；贝伐单抗：+0.3 个字母 [P=0.85]；雷珠单抗：+1.1 个字母 [P=0.40]）。阿柏西普两年内 VA 的平均字母变化（曲线下面积）（+17.1±9.7）大于贝伐单抗（+12.1±9.4，P<0.001）或雷珠单抗（+13.6±8.5，P=0.009）。当 VA 为 20/50 或更差时，贝伐珠单抗在一年内降低 CST 的程度低于其他药物；但两年后，差异就缩小了。该 VA 亚组的分层分析还根据研究期间是否针对 DME 给予聚焦/网格激光进行分层，发现仅在接受激光的贝伐珠单抗治疗的眼睛中，CST 从一到两年显着下降（-55um，P=0.0001）。尽管考虑到潜在的偏倚，事后分析应谨慎看待，但这些结果探讨了临床相关问题，为解释这些比较有效性结果提供了进一步的信息。
Post-hoc analyses from DRCR.net randomized trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional post-hoc clinically relevant outcomes comparing three anti-VEGF agents for DME Post-hoc analysis from a 2-year randomized clinical trial of 660 participants comparing three anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Random allocation to intravitreous aflibercept (2.0-mg), bevacizumab (1.25-mg) or ranibizumab (0.3-mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser was added after 6 months for persistent DME. Change in visual acuity area under the curve; change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study For eyes with initial visual acuity (VA) 20/50 or worse, VA improvement was greater with aflibercept than the other agents at one year, but superior only to bevacizumab at the two year visit. VA remained largely stable from one to two years (aflibercept: −1.2 letters [P=0.24]; bevacizumab: +0.3 letters [P=0.85]; ranibizumab: +1.1 letters [P=0.40]). Average letter change in VA over two years (area under curve) was greater with aflibercept (+17.1±9.7) than bevacizumab (+12.1±9.4, P<0.001) or ranibizumab (+13.6±8.5, P=0.009). When VA was 20/50 or worse, bevacizumab reduced CST less than the other agents at one year; but at two years the differences had diminished. Stratified analyses in this VA subgroup additionally stratified by whether focal/grid laser was given for DME during the study found a significant decrease in CST from one to two years only in bevacizumab-treated eyes receiving laser (−55um, P=0.0001). Although post-hoc analyses should be viewed with caution given the potential for bias, these results explore clinically relevant questions giving further information for interpretation of these comparative effectiveness results.