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

Br J Ophthalmol. 2022 Feb;106(2):246-250. doi: 10.1136/bjophthalmol-2020-316514. Epub 2020 Oct 30.

Abstract

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-naïve 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, μm) 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.

Keywords: Neovascularisation; Retina; Vitreous.

Publication types

  • Observational Study

MeSH terms

  • Angiogenesis Inhibitors / therapeutic use
  • Humans
  • Intravitreal Injections
  • Macular Degeneration* / drug therapy
  • Receptors, Vascular Endothelial Growth Factor / therapeutic use
  • Recombinant Fusion Proteins / therapeutic use
  • Tomography, Optical Coherence / methods
  • Treatment Outcome
  • Visual Acuity
  • Wet Macular Degeneration* / diagnosis
  • Wet Macular Degeneration* / drug therapy

Substances

  • Angiogenesis Inhibitors
  • Recombinant Fusion Proteins
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor