Two-year results from the VISTA and VIVID studies show aflibercept produced superior visual and anatomic improvement in patients with diabetic macular edema (DME) compared with laser treatment. As important, results showed 8-week doing regimen was as effective as monthly dosing.
Given the burden of DME in the working age population where monthly treatment may not be feasible, the results of the present study demonstrate that patients may achieve clinically meaningful improvements in visual acuity with less frequent dosing of intravitreal aflibercept.
Patients received either 2 mg of aflibercept every 4 weeks, 2 mg of aflibercept every 8 weeks following 5 monthly doses, or laser photocoagulation. At 100 weeks, the aflibercept groups showed superior visual and anatomic improvement (P<0.0001). Additionally, each regimen of aflibercept was superior to laser in stopping diabetic retinopathy progression based on the ETDRS scale. Incidence of adverse events was low across all treatment groups.
Additionally, significantly more patients in the aflibercept groups gained more than 15 letters from baseline and had at minimum 2-step improvement in the DRSS score.
In the monthly regimen, patients received 12 injections the first year followed by 10 injections during the second year. In comparison, patient dosed every 8 weeks received 8.5 injections during year 1, followed by 5 injections in year 2.
The results of the present study may also be interpreted in the context of the DRCR Networks Protocol T data, which compared intravitreal aflibercept, ranibuzumab and bevacizumab for DME. Similar to the current study, Protocol T data found that after 1 year, patients dosed every other month received on average 9 injections and gained on average 13 letters. When stratified by baseline visual acuity, however, patients with less than 20/50 acuity gained approximately 19 letters. Further studies from the VISTA and VIVID clinical trials may be warranted to confirm this finding.