High dose aflibercept may be promising for treatment of age-related macular degeneration

1. Aflibercept 8 mg was non-inferior to 2 mg for best-corrected visual acuity at 48 weeks.

2. Ocular adverse events were comparable across treatment groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Neovascular age-related macular degeneration (nAMD) is a major cause of vision loss worldwide. Anti-vascular endothelial growth factors, such as aflibercept, may improve treatment outcomes and sustain disease control, although further research is needed. This randomized controlled trial aimed to assess the safety and efficacy of high-dose aflibercept versus standard dose for nAMD. The primary outcome was change in best-corrected visual acuity (BCVA) from baseline to 48 weeks, while a key secondary outcome was the incidence of ocular adverse events. According to study results, high dose aflibercept was non-inferior to the standard dose, with similar rates of adverse events. Although this study was well done, it was limited by the need for long-term follow-up to assess sustained efficacy and safety.

Click to read the study in The Lancet

Relevant Reading: Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration

In-depth [randomized-controlled trial]: Between Aug 11, 2020, and Jul 30, 2021, 1395 patients were assessed for eligibility across 223 sites worldwide. Included were patients ≥ 50 years old with a confirmed diagnosis of nAMD. Eligible patients were randomly assigned to receive aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8). Altogether, 1009 patients (335 in 8q12, 338 in 8q16, and 336 in 2q8) were included in the final analysis. The primary outcome of change in BCVA from baseline to 48 weeks was non-inferior in aflibercept 8q12 and 8q16 versus aflibercept 2q8 (mean BCVA change +6.7 [standard deviation {SD} 12.6] letters and +6.2 [SD 11.7] letters vs. +7.6 [SD 12.2] letters). The secondary outcome of ocular adverse events was similar across groups (39% in 8q12, 38% in 8q16, and 39% in 2q8). Overall, findings from this study suggest that aflibercept 8 mg with extended dosing intervals could offer efficacy and safety benefits for patients with nAMD.

Image: PD

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