IVT-AFL treat-and-extend effective for neovascular AMD
In patients who previously received ≥1 year of intravitreal aflibercept (IVT-AFL) treatment for neovascular age-related macular degeneration (nAMD), tread-and-extend (T&E) dosing achieved similar functional outcomes as every-8-week dosing (q8) and T&E required fewer injections. Functional and anatomic improvements achieved during year 1 (Y1) were maintained through year 3 (Y3) of IVT-AFL treatment with both regimens, according to a study presented at ARVO 2021.
The randomized, multicenter AZURE study compared the efficacy and safety of the dosing regimens for patients with nAMD beyond year 1 of treatment. Patients were randomized to fixed q8 (2mg IVT-AFL every 8 weeks [w]) or T&E dosing (IVT-AFL ≥8w). The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline to week 52, while the key secondary endpoint was proportion of patients losing <15 letters.
The full analysis included 332 patients (n=167 [q8] and n=165 [T&E]). Mean BCVA at IVT-AFL treatment initiation was 60.9 (9.9; q8) and 59.4 (10.5; T&E) letters. At study baseline, mean BCVA was 70.1 (10.9; q8) and 69.0 (12.1; T&E) letters. At week 52, mean BCVA change from baseline was −0.5 (8.4; q8) and −0.3 (7.5; T&E) letters. Compared with q8 dosing, T&E achieved a non-inferior change in mean BCVA at w52. At week 76, mean BCVA change from baseline was −0.9 (10.4; q8) and −1.5 (10.9; T&E) letters. From baseline to week 52, 94.% (q8) and 95.2% (T&E) of patients maintained vision (<15-letter loss). Adverse events in the study eye were similar for both dosing regimens.
Kodjikian L, et al. Efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) compared with fixed dosing (q8) for neovascular age-related macular degeneration (nAMD): The AZURE study. Presented at ARVO 2021.