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.

• Authors: Jeffrey S Heier, David M Brown, Victor Chong, Jean-Francois Korobelnik, Peter K Kaiser, Quan Dong Nguyen, Bernd Kirchhof, Allen Ho, Yuichiro Ogura, George D Yancopoulos, Neil Stahl, Robert Vitti, Alyson J Berliner, Yuhwen Soo, Majid Anderesi, Georg Groetzbach, Bernd Sommerauer, Rupert Sandbrink, Christian Simader, Ursula Schmidt-Erfurth, VIEW 1 and VIEW 2 Study Groups
• Journal: Ophthalmology (Ophthalmology) Vol. 119 Issue 12 Pg. 2537-48 (Dec 2012) ISSN: 1549-4713 [Electronic] United States
• PMID: 23084240 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Antibodies, Monoclonal, Humanized
• Recombinant Fusion Proteins
• aflibercept
• Receptors, Vascular Endothelial Growth Factor
• Ranibizumab

Topics

• Aged
• Angiogenesis Inhibitors (therapeutic use)
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Double-Blind Method
• Female
• Fluorescein Angiography
• Humans
• Intravitreal Injections
• Male
• Prospective Studies
• Ranibizumab
• Receptors, Vascular Endothelial Growth Factor
• Recombinant Fusion Proteins (adverse effects, therapeutic use)
• Retreatment
• Sickness Impact Profile
• Treatment Outcome
• Visual Acuity (physiology)
• Wet Macular Degeneration (diagnosis, drug therapy, physiopathology)