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首页> 外文期刊>Journal of vitreoretinal diseases. >Intravitreal Nesvacumab (Anti-Angiopoietin-2) Plus Aflibercept in Neovascular AMD: Phase 2 ONYX Randomized Trial
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Intravitreal Nesvacumab (Anti-Angiopoietin-2) Plus Aflibercept in Neovascular AMD: Phase 2 ONYX Randomized Trial

机译：玻璃体内注射 Nesvacumab（抗血管生成素-2）联合阿柏西普治疗新生血管性 AMD：2 期 ONYX 随机试验

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Purpose: To compare intravitreal nesvacumab (anti-angiopoietin-2)?+?aflibercept vs intravitreal aflibercept injection (IAI) in neovascular age-related macular degeneration (nAMD). Methods: Eyes were randomized (1:2:3) to nesvacumab 3 mg?+?aflibercept 2 mg (LD combo), nesvacumab 6 mg?+?aflibercept 2 mg (HD combo), or IAI 2 mg at baseline, week 4, and week 8. The LD combo was continued every 8 weeks (q8w). At week 12, the HD combo was re-randomized to q8w or every 12 weeks (q12w) and IAI was re-randomized to q8w, q12w, or HD combo q8w through week 32. Results: The study comprised 365 eyes. At week 12, the mean best-corrected visual acuity (BCVA) gains from baseline were similar in the LD combo group, HD combo group, and IAI group (5.2 letters, 5.6 letters, and 5.4 letters, respectively); the mean central subfield thickness (CST) reductions were similar (182.2 μm, 200.0 μm, and 178.6 μm, respectively). The mean changes in BCVA and CST through week 36 were similar across groups. At week 12, complete retinal fluid resolution was observed in 49.1% (LD combo), 50.8% (HD combo), and 43.6% (IAI) of eyes; the proportions with a CST of 300 μm or less were similar across groups. Numerical trends at week 32 toward complete retinal fluid resolution with combination treatment were not maintained at week 36. Serious ocular adverse events were infrequent and comparable across groups. Conclusions: In nAMD, nesvacumab?+?aflibercept showed no additional BCVA or CST benefit over IAI monotherapy.
机译：目的:比较intravitreal nesvacumab(anti-angiopoietin-2) + ?intravitreal aflibercept注入(IAI)新生血管性年龄相关性黄斑变性(nAMD)。nesvacumab 3毫克+ ?nesvacumab 6毫克+ ?IAI 2毫克基线,星期4,星期8。组合继续每8周(q8w)。12、高清re-randomized q8w或组合每12周(q12w)和IAI re-randomizedq12w q8w,或高清组合q8w 32周。结果:研究由365眼。12日的平均最佳矫正视力(BCVA)LD组合收益基本相似组、高清组合组,IAI组(5.2书信,5.6,和5.4信件,分别);厚度(CST)减少类似的(182.2μm, 200.0μm和178.6μm,分别)。意味着BCVA和春秋国旅的变化通过36周类似的跨组。视网膜流体决议中观察到49.1%(LD组合),50.8% (HD组合),43.6% (IAI)眼睛;少被类似的跨组。在32周向完整视网膜流体分辨率与联合治疗维持在36周。事件是罕见,可比组。nesvacumab + ?BCVA或春秋国旅在IAI公司单方受益。

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