Of the 3 regimens, monthly aflibercept produced the greatest gain in mean BCVA.
Despite treatment with anti-vascular endothelial growth factor (VEGF) agents, some eyes with neovascular age-related macular degeneration (nAMD) continue to retain fluid within or beneath the retina, and this persistent fluid correlates with worse visual acuity.
To determine which agent and dosing regimen is best for these patients, a research team recently did a post hoc analysis of data on nearly 2,000 eyes with nAMD evaluated in the VIEW 1 and 2 trials. The team included members from the Department of Ophthalmology at Duke University in Durham, North Carolina, the Cole Eye Institute in Cleveland, Ohio, Ophthalmic Consultants of Boston, Massachusetts, and Regeneron Pharmaceuticals, Tarrytown, New York.
Based on these two phase 3 VIEW trials, the US Food and Drug Administration (FDA) approved 2-mg intravitreal injections of aflibercept (Eylea, Regeneron), given monthly or bimonthly after three initial doses, to treat nAMD. In VIEW 1 and 2, results of both of these treatment regimens were compared with those of monthly 0.5-mg intravitreal injections of ranibizumab (Lucentis/Roche).
The post hoc analysis included data on 1,815 eyes of patients with known fluid status at baseline and after one, two, and three months of treatment with aflibercept or ranibizumab. Each of the three treatment groups by regimen included approximately 600 patients, or one-third of the total group.
Main outcome measures for the analysis included mean change in best-corrected visual acuity (BCVA) from baseline after four months to one year as well as the proportion of eyes that gained at least 15 letters or lost at least five letters.
Eyes were evaluated based on the presence or absence of persistent fluid by fluid type, which was classified as either cystic intraretinal or subretinal. Persistent fluid was defined as fluid that remained after three initial monthly injections of an anti-VEGF agent.
The investigators found that nearly 30% of eyes in the ranibizumab group had persistent fluid, compared with approximately 20% of eyes in the monthly or bimonthly aflibercept groups.
In eyes with persistent fluid, patterns of visual outcomes were similar regardless of fluid type. Mean increase in BCVA was greatest in the monthly aflibercept group. More specifically, mean gain in BCVA from baseline after 1 year was significantly greater for monthly aflibercept than monthly ranibizumab (P < 0.01) but similar for monthly ranibizumab and bimonthly aflibercept (P = 0.29). In contrast, changes in BCVA in eyes without persistent fluid were similar across all three treatment groups.
Moreover, after one year of anti-VEGF treatment, nearly 40% fewer eyes with persistent fluid treated with monthly aflibercept (6.5%) lost at least five letters than eyes treated with either monthly ranibizumab (16.6%) or bimonthly aflibercept (16.2%). However, a similar proportion of eyes with persistent fluid in each group gained at least 15 letters.
In a recent blog post, post hoc study co-author Peter Kaiser, MD, of the Cole Eye Institute characterized these results as unsurprising because other studies found that aflibercept dried the retina better than ranibizumab.
According to Kaiser, staff at his institute typically begin treating nAMD patients with bevacizumab (Avastin/Roche), and if improvement is insufficient, switch treatment to aflibercept or ranibizumab. However, Kaiser noted, “With these findings, we are now much more likely to choose monthly aflibercept injections for eyes that continue to have persistent leakage.”
The study report, “Differential response to anti-VEGF regimens in age-related macular degeneration patients with early persistent retinal fluid,” was published in the September, 2016, issue of Ophthalmology.