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Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

Abstract：

OBJECTIVE:Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. DESIGN:Double-masked, multicenter, parallel-group, active-controlled, randomized trials. PARTICIPANTS:Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. INTERVENTION:Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). MAIN OUTCOME MEASURES:The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. RESULTS:All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. CONCLUSIONS:Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found after the references.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

Heier JS,Brown DM,Chong V,Korobelnik JF,Kaiser PK,Nguyen QD,Kirchhof B,Ho A,Ogura Y,Yancopoulos GD,Stahl N,Vitti R,Berliner AJ,Soo Y,Anderesi M,Groetzbach G,Sommerauer B,Sandbrink R,Simader C,Schmidt-Erfurth U,VIE

doi

10.1016/j.ophtha.2012.09.006

subject

Has Abstract

pub_date

2012-12-01 00:00:00

pages

2537-48

issue

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(12)00865-2

journal_volume

119

pub_type

杂志文章,多中心研究,随机对照试验

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Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.