Data show patients can decrease annual injections while retaining, if not improving, on BCVA scores over 104 weeks.
A treat-and-extend (T&E) regimen of aflibercept (Eylea) could provide comparable benefit for patients with diabetic macular edema (DME) at 2 years, according to new findings presented at the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting.
In new data presented by a team of investigators, led by study author Min Sagong, MD, the Regeneron anti-vascular endothelial growth factor (anti-VEGF) injection therapy showed improvement of visual acuity in patients with DME through up 104 weeks of care.
The outcomes follow previous year’s research showing aflibercept bettered anti-VEGF therapies ranibizumab and bevacizumab in one-year outcomes for patients with DME.
Sagong and colleagues conducted the prospective, multicenter, single-arm assessment of aflibercept with a pool of 46 patients with DME. Trial participants received 5 monthly injections of 2mg aflibercept, before being adjusted to an injection interval of 2 weeks based on observed changes to the central subfield macular thickness (CSMT).
Investigators were observing patients for a primary outcome of changes in best corrected visual corrected visual acuity (BCVA) from baseline at 104 weeks.
At 52 weeks, patients reported a significant improvement of plus 9.1 letters in BCVA from baseline. By 104 weeks, they had maintained a mean plus 9.4 letters improvement in BCVA (P <.001).
More than one-third (34.8%) of observed eyes gained ≥15 letters in BCVA scoring at 104 weeks.
CMST decreased by -191 mcm from baseline at 104 weeks (P <.001). Mean aflibercept injections were 8.5 per patient at 52 weeks, then decreased to just 3.9 per patient in the following 52 weeks. Injection interval was extended to 12 weeks in more than half (56.5%) of all treated patients with DME.
Sagong and colleagues concluded the observed efficacy of aflibercept at 104 weeks—coupled with previous outcomes showing its benefit versus competitors at shorter durations—indicate its longterm benefit and tolerability for eligible patients with DME.
“The T&E regimen for DME of the current study, using aflibercept, showed 2-year efficacy comparable to the fixed-dosing regimen of the pivotal trials,” investigators wrote. “The flexible dosing of T&E would avoid overtreatment without losing the expected efficacy.”
The study, “Two-Year Results of T&E Regimen Using Aflibercept for DME: The VIBIM study,” was presented at AAO 2020.