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阿柏西普玻璃体内注射治疗以非亚洲人群为主的新生血管性息肉状脉络膜血管病变:RIVAL研究结果

Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy in a Predominantly Non-Asian Population: RIVAL Results.

作者信息

Farooq Amina, Frazier Heather, Marcus William B, Fechter Chelsea, Singh Harinderjit, Marcus Dennis M

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2017 Jan 1;48(1):34-52. doi: 10.3928/23258160-20161219-05.

Abstract

BACKGROUND AND OBJECTIVE

To evaluate safety and efficacy of intravitreal aflibercept (Eylea; Regeneron, Tarrytown, NY) injection (IAI) for the treatment of neovascular polypoidal choroidal vasculopathy (PCV) in a predominantly non-Asian population.

PATIENTS AND METHODS

This was an open-label, prospective, unmasked, nonrandomized clinical trial. Twenty eyes with neovascular PCV received monthly 2.0 mg IAI for 3 months followed by mandatory IAI every 2 months for 12 months.

RESULTS

The mean change in ETDRS best-corrected visual acuity from baseline to 1 year was +11 letters in the treatment-naïve group, +5 letters in the treatment non-naïve group, and +9 letters overall. There was an overall mean reduction of 70 µm from baseline central subfield thickness (CST) at 1 year. Patients received a mean of 6.2 mandatory and 0.7 additional IAI injections overall during the course of 1 year. No serious ocular adverse events were reported.

CONCLUSION

At 1 year, neovascular PCV in a predominantly non-Asian population treated with IAI demonstrated favorable visual, anatomic, and safety outcomes. [Ophthalmic Surg Lasers Imaging Retina. 2017;48:34-44.].

摘要

背景与目的

在以非亚洲人群为主的患者中,评估玻璃体内注射阿柏西普(阿瓦斯汀;再生元公司,纽约州塔里敦)(IAI)治疗新生血管性息肉状脉络膜血管病变(PCV)的安全性和有效性。

患者与方法

这是一项开放标签、前瞻性、非盲、非随机的临床试验。20例新生血管性PCV患者每月接受2.0mg IAI注射,共3个月,随后每2个月强制注射IAI,持续12个月。

结果

初治组从基线到1年的ETDRS最佳矫正视力平均变化为+11个字母,非初治组为+5个字母,总体为+9个字母。1年时,中央子野厚度(CST)较基线平均总体降低70µm。患者在1年的疗程中平均接受了6.2次强制注射和0.7次额外的IAI注射。未报告严重的眼部不良事件。

结论

在1年时,以非亚洲人群为主的新生血管性PCV患者接受IAI治疗后,在视力、解剖结构和安全性方面均取得了良好的效果。[眼科手术激光成像视网膜。2017;48:34-44。]

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