Aflibercept for age-related macular degeneration: 4-year outcomes of a 'treat-and-extend' regimen with exit-strategy

Aim To report long-term outcomes on best-corrected visual acuity (BCVA) and treatment intervals with a treat-and-extend (T&E) regimen in patients with neovascular age-related macular degeneration (nAMD). Methods This observational study included treatment-naive patients with nAMD, treated with aflibercept. A specific T&E protocol without a loading phase and predefined exit criteria was administered. After reaching predefined 'exit-criteria', the treatment period was complete, and patients were observed three monthly. Results Eighty-two patients with a follow-up period of >= 2 years were included. BCVA (mean +/- SD, ETDRS letters) increased from 51.9 +/- 25.2 at baseline to 63.7 +/- 17.7 (p<0.0001) at 1 year, 61.7 +/- 18.5 (p<0.0001) at 2 years, 62.4 +/- 19.5 (p<0.0001, n=61) at 3 years and remained insignificantly higher than baseline at 4 years at 58.5 +/- 24.3 (p=0.22). Central subfield thickness (mean +/- SD, mu m) decreased significantly from 387.5 +/- 107.6 (p<0.0001) at baseline to 291.9 +/- 65.5 (p<0.0001) at 1 year, and remained significantly lower until 4 years at 289.0 +/- 59.4 (p<0.0001). Treatment intervals (mean +/- SD, weeks) could be extended up to 9.3 +/- 3.1 weeks at 1 year and remained at 11.2 +/- 3.5 weeks at 4 years. Twenty-nine (35%) patients reached exit criteria and continued with three monthly observation only. Conclusions After 4 years of treatment, initial vision gains were maintained with a reasonable treatment burden, even without an initial loading phase. Our results on functional outcomes are comparable with large controlled studies.