COMMENTARY

VEGF Trap-Eye: Looking Good for AMD

Vaidehi S. Dedania, MD; Sophie J. Bakri, MD

Disclosures

April 29, 2013

Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-Related Macular Degeneration

Heier JS, Brown DM, Chong V, et al; VIEW 1 and VIEW 2 Study Groups.
Ophthalmology. 2012;119:2537-2548.

Study Summary

Aflibercept is a soluble decoy fusion protein that binds all isoforms of vascular endothelial growth factor (VEGF) with a greater binding affinity than ranibizumab. Intravitreal aflibercept is US Food and Drug Administration (FDA)-approved for the treatment of neovascular age-related macular degeneration (AMD).

In 2 double-masked, multicenter, parallel-group, active-controlled, randomized trials in 2419 patients, intravitreal aflibercept (dosed monthly or every 2 months after 3 initial monthly doses) was compared with monthly intravitreal ranibizumab for the treatment of neovascular AMD.

Patients were randomly assigned to 1 of the following treatment regimens in a 1:1:1:1 ratio:

  • 0.5 mg aflibercept every 4 weeks;

  • 2 mg aflibercept every 4 weeks;

  • 2 mg aflibercept every 8 weeks after 3 injections at weeks 0, 4, and 8; or

  • 0.5 mg ranibizumab every 4 weeks.

The primary endpoint was noninferiority of the aflibercept regimens to ranibizumab in patients maintaining vision at 52 weeks (loss of < 15 ETDRS letters).

Secondary endpoints included changes in best-corrected visual acuity, choroidal neovascularization area on fluorescein angiography, and the National Eye Institute Visual Function Questionnaire 25 assessments. Exploratory and post hoc endpoints of changes in retinal thickness and persistence of fluid as assessed by optical coherence tomography were also examined. Patient examinations were performed on the day of treatment initiation, 1 week after treatment initiation, and at 4-week intervals from treatment initiation through 52 weeks.

In each study, the primary endpoint of the proportion of patients maintaining vision was similar in all treatment groups. The proportion of patients gaining 15 or more ETDRS letters at 52 weeks and reporting improved vision-related quality of life on the Visual Function Questionnaire 25 were also similar in all groups. The group that received 2 mg aflibercept every 8 weeks achieved a mean visual acuity score within 0.3 letter of the ranibizumab group. All intravitreal aflibercept groups were similar to the ranibizumab group in terms of the percentage of patients who had fluid-free retinas on optical coherence tomography. The safety of intravitreal aflibercept and ranibizumab were also comparable, with similar overall incidences of systemic adverse events, serious systemic adverse events, specific arterial thromboembolic endpoints, and death.

Viewpoint

The clinical implications of this study are important for physicians and their patients. Intravitreal aflibercept dosed at 2 mg every 8 weeks reduces the treatment burden for patients, with the added benefit of ocular safety as a result of less frequent injections. The study was important to the FDA approval of aflibercept. However, we do not know whether similar results would have been achieved if ranibizumab dosed every 8 weeks was compared with aflibercept every 8 weeks. There is potential for further studies for comparisons of as-needed dosing, or a treat-and-extend dosing regimen, for both drugs.

Abstract

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