Heier Jeffrey S, Ho Allen C, Boyer David S, Csaky Karl, Vitti Robert, Perlee Lorah, Chu Karen W, Asmus Friedrich, Leal Sergio, Zeitz Oliver, Cheng Yenchieh, Schmelter Thomas, Brown David M
Ophthalmic Consultants of Boston, Boston, MA, USA.
Wills Eye Hospital, Philadelphia, PA, USA.
J Vitreoretin Dis. 2022 Dec 30;7(1):8-15. doi: 10.1177/24741264221126061. eCollection 2023 Jan-Feb.
To compare intravitreal nesvacumab (anti-angiopoietin-2) + aflibercept vs intravitreal aflibercept injection (IAI) in neovascular age-related macular degeneration (nAMD).
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.
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.
In nAMD, nesvacumab + aflibercept showed no additional BCVA or CST benefit over IAI monotherapy.
比较玻璃体内注射奈斯伐umab（抗血管生成素-2）+阿柏西普与玻璃体内注射阿柏西普（IAI）治疗新生血管性年龄相关性黄斑变性（nAMD）的效果。
在基线、第4周和第8周时，将眼睛随机分为（1:2:3）三组，分别接受3毫克奈斯伐umab + 2毫克阿柏西普（低剂量联合组）、6毫克奈斯伐umab + 2毫克阿柏西普（高剂量联合组）或2毫克IAI。低剂量联合组每8周（q8w）给药一次。在第12周时，高剂量联合组重新随机分为q8w或每12周（q12w）给药一次，IAI组重新随机分为q8w、q12w或高剂量联合组q8w，直至第32周。
该研究共纳入365只眼睛。在第12周时，低剂量联合组、高剂量联合组和IAI组从基线开始的平均最佳矫正视力（BCVA）增益相似（分别为5.2个字母、5.6个字母和5.4个字母）；平均中心子场厚度（CST）降低相似（分别为182.2微米、200.0微米和178.6微米）。到第36周时，各组的BCVA和CST平均变化相似。在第12周时，49.1%（低剂量联合组）、50.8%（高剂量联合组）和43.6%（IAI组）的眼睛观察到视网膜积液完全消退；各组CST为300微米或更小的比例相似。在第32周时联合治疗使视网膜积液完全消退的数值趋势在第36周时未得到维持。严重眼部不良事件很少见，且各组之间具有可比性。
在nAMD中，奈斯伐umab + 阿柏西普相较于IAI单药治疗，在BCVA或CST方面未显示出额外益处。
