Comparison of aflibercept treatment regimes for treatment-resistant neovascular age-related macular degeneration: 8 weekly versus an ‘as-needed’ regime

Abstract

Purpose: The optimal treatment regime for patients with neovascular age-related macular degeneration (nAMD) resistant to anti-vascular endothelial growth factor (anti-VEGF) agents is currently unknown. This study prospectively compared the efficacy of intravitreal aflibercept administered every 8 weeks versus an ‘as-needed’ treatment regime over 48-weeks

Methods: Patients with nAMD previously resistant to other anti-VEGF agents were recruited into 2 different aflibercept treatment regimes and prospectively assessed for 48 weeks. Group-A: 49 patients treated with 3 initial loading doses every 4 weeks followed by mandated injections every 8 weeks for 48 weeks. Group-B: 52 patients treated using a spectral-domain optical coherence tomography guided ‘as-needed’ treatment regime. Change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to 48 weeks were compared between the groups using two sample t-tests

Results: Mean age was similar between the groups (77.3±7.5 vs. 77.1±17.1 years, p=0.93). Group-A had 8 mandated injections and Group-B had a mean of 10.0±1.2 injections over 48 weeks (p<0.001). Mean baseline BCVA was 60.5±16.2 and 64.9±17.4 letters in Groups A and B respectively (p=0.19), and improved by 4.7±9.1 and 0.2±9.0 letters at week 48 in Groups A and B respectively (p=0.01). Baseline mean CMT was 448.4±141.2µm and 390.4±141.3µm for Groups A and B respectively (p=0.04), and reduced by 97.2±149.3µm and 89.6±105.9µm at week 48 in Groups A and B respectively (p=0.77).

Conclusions: Both 8 weekly and ‘as needed’ intravitreal aflibercept treatment regimes were effective in maintaining vision and anatomical outcomes in treatment-resistant nAMD patients. Eight weekly injection regime produced a better visual outcome with fewer injections than the ‘as-needed’ regime over 48 week study period. Randomized long-term clinical trials with a large cohort size are necessary in this treatment-resistant population to examine the efficacy of these treatment regimes