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玻璃体内注射阿柏西普和雷珠单抗在新生血管性年龄相关性黄斑变性中的延长(每 12 周或更长时间)给药间隔:VIEW 试验的事后分析。

Extended (Every 12 Weeks or Longer) Dosing Interval With Intravitreal Aflibercept and Ranibizumab in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of VIEW Trials.

机构信息

Northern California Retina Vitreous Associates, Mountain View, California, USA.

Palo Alto Medical Foundation, Palo Alto, California, USA.

出版信息

Am J Ophthalmol. 2019 Apr;200:161-168. doi: 10.1016/j.ajo.2019.01.005. Epub 2019 Jan 19.

Abstract

PURPOSE

To evaluate outcomes and disease characteristics in eyes with neovascular age-related macular degeneration that received intravitreal aflibercept injection (IAI) and ranibizumab every 12 weeks or longer (≥q12 weeks) or less than every 12 weeks (<q12 weeks) during year 2 of VIEW studies.

DESIGN

Post hoc analysis of randomized clinical trial data.

METHODS

In year 1, eyes received ranibizumab q4 weeks (Rq4), IAI 2 mg q4 weeks (2q4), or IAI 2 mg q8 weeks after 3 monthly injections (2q8). In year 2, eyes received pro re nata treatment, with mandatory treatment at least q12 weeks.

RESULTS

At week 96, 218 (42.5%), 284 (53.9%), and 245 (47.9%) eyes treated with Rq4, 2q4, and 2q8, respectively, received treatment at ≥q12-week intervals and 295 (57.5%), 243 (46.1%), and 266 (52.1%) eyes at <12q-week intervals during the second year. Baseline occult-type choroidal neovascularization (CNV) (P = .0156) and retinal fluid (P < .0001) and leakage (P < .0001) at week 52 were associated with <q12-week dosing. Mean best-corrected visual acuity gains from baseline with Rq4, 2q4, and 2q8 at ≥q12-week interval were 8.7, 9.9, and 9.7 letters at week 52 and 8.5, 8.8, and 9.2 letters at week 96, respectively. The corresponding gains with <q12-week dosing were 10.3, 9.7, and 8.9 letters at week 52 and 9.1, 7.7, and 8.1 letters at week 96.

CONCLUSIONS

Baseline CNV type other than occult and absence of retinal fluid and leakage at week 52 were significantly associated with ≥q12-week dosing. Vision improvements at week 52 following a year of fixed dosing with ranibizumab and IAI were maintained at week 96 in eyes that received treatment ≥q12 weeks and <q12 weeks.

摘要

目的

评估在 VIEW 研究的第 2 年中,接受玻璃体内阿柏西普注射(IAI)和雷珠单抗每 12 周或更长时间(≥q12 周)或每 12 周以下(<q12 周)治疗的新生血管性年龄相关性黄斑变性(AMD)眼的治疗效果和疾病特征。

设计

随机临床试验数据的事后分析。

方法

在第 1 年,眼睛接受雷珠单抗 q4 周(Rq4)、IAI 2 毫克 q4 周(2q4)或 IAI 2 毫克 q8 周(2q8),每月 3 次注射后。在第 2 年,眼睛接受了按需治疗,至少每 12 周进行一次强制性治疗。

结果

在第 96 周时,分别接受 Rq4、2q4 和 2q8 治疗的 218(42.5%)、284(53.9%)和 245(47.9%)只接受了≥q12 周的治疗间隔,而在第 2 年期间,295(57.5%)、243(46.1%)和 266(52.1%)只接受了<q12 周的治疗间隔。第 52 周时,隐匿型脉络膜新生血管(CNV)(P =.0156)和视网膜液(P <.0001)和渗漏(P <.0001)与<q12 周的剂量有关。从基线开始,接受 Rq4、2q4 和 2q8 治疗的最佳矫正视力在≥q12 周间隔时的平均增益分别为第 52 周时 8.7、9.9 和 9.7 个字母,第 96 周时为 8.5、8.8 和 9.2 个字母。接受<q12 周剂量治疗的增益分别为第 52 周时 10.3、9.7 和 8.9 个字母,第 96 周时为 9.1、7.7 和 8.1 个字母。

结论

第 52 周时 CNV 类型除隐匿型外,以及无视网膜液和渗漏与≥q12 周剂量显著相关。在接受雷珠单抗和 IAI 固定剂量治疗 1 年后,在第 52 周时观察到的视力改善在第 96 周时仍保持在≥q12 周和<q12 周治疗的眼睛中。

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