The treatment of center-involving diabetic
macular edema (DME) has improved because of the proven efficacy of drugs that inhibit the effects of
vascular endothelial growth factor (
VEGF). The newest anti-
VEGF drug,
aflibercept, has recently been approved by the United States Food and Drug Administration for the treatment of center-involving DME and for
diabetic retinopathy in eyes with DME. In the pivotal Phase III VISTA and VIVID trials, intravitreal
aflibercept 2 mg
injections every 4 or 8 weeks (after 5 monthly loading doses) produced superior gains in BCVA compared to
laser/
sham injections. In the
Diabetic Retinopathy Clinical Research Network Protocol T trial, which featured monthly anti-
VEGF monotherapy for 6 months, followed by monthly pro re
nata anti-
VEGF injections with
laser rescue
therapy from months 6 through 12,
aflibercept 2 mg monthly was superior to
bevacizumab 1.25 mg and
ranibizumab 0.5 mg in eyes with BCVA of 20/50 or worse (
aflibercept versus
bevacizumab: P<0.001;
aflibercept versus
ranibizumab: P=0.003), but the three regimens were comparable for eyes with VA of 20/40 or better. Only in the 20/50 or worse subgroup did
aflibercept achieve clinical superiority (>5 letter difference) to
bevacizumab. Each treatment regimen led to significant macular thinning, with
aflibercept being superior to
bevacizumab in both visual acuity subgroups (P<0.001 for each), but it was not statistically superior to
ranibizumab in either group. In diabetic patients,
aflibercept has an excellent safety profile that does not appear to differ from
laser/
sham or other
VEGF inhibitory drugs.