Double-dose investigation of aflibercept in neovascular age-related macular degeneration (DIANA): a real-world study

BMC Ophthalmol. 2024 May 17;24(1):215. doi: 10.1186/s12886-024-03476-9.

Abstract

Background: To investigate the clinical effects of double-dose (4 mg) aflibercept treatment in neovascular age-related macular degeneration (nAMD), compared with the standard-dose (2 mg) treatment.

Methods: A total of 108 eyes from 97 patients with nAMD and received intravitreal aflibercept 2 mg and/or 4 mg treatment were retrospectively reviewed. The changes of central macular thickness (CMT)/ pigmental epithelium detachment height and the recurrence rate of exudation during the 12-month follow-up were compared between the 2 mg group and the 4 mg group. Self-control comparisons (2 mg switch to 4 mg) were also made between two regimens.

Results: Compared with the 2 mg group, tendencies of lower intraretinal fluid incidence and more CMT reduction were observed in the 4 mg group. The later one was also observed when eyes switching from 2 mg to 4 mg regimen. The median remission interval was 5 months in the 4 mg group, 2 months longer than the 3 months in the 2 mg group (P = 0.452). Injections needed in the 4 mg group were 3.644 ± 1.670, less than the 4.286 ± 2.334 injections in the 2 mg group within 12 months as well (P = 0.151). However, no associated vision benefits were gained from the double-douse regimen. No markedly increased-intraocular pressure events, or other adverse events were found in two groups.

Conclusions: Compared to the aflibercept 2 mg treatment in nAMD, tendencies of anatomic gains and relieving treatment burden were brought by the aflibercept 4 mg treatment. This study may have additional importance, given the further application of high-dose aflibercept in real-world settings.

Keywords: Aflibercept; Anti-VEGF treatment; High-dose; Neovascular age-related macular degeneration; Real-world study.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors* / administration & dosage
  • Angiogenesis Inhibitors* / therapeutic use
  • Dose-Response Relationship, Drug
  • Female
  • Fluorescein Angiography / methods
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections*
  • Male
  • Receptors, Vascular Endothelial Growth Factor* / administration & dosage
  • Receptors, Vascular Endothelial Growth Factor* / therapeutic use
  • Recombinant Fusion Proteins* / administration & dosage
  • Recombinant Fusion Proteins* / therapeutic use
  • Retrospective Studies
  • Tomography, Optical Coherence* / methods
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity* / physiology
  • Wet Macular Degeneration* / diagnosis
  • Wet Macular Degeneration* / drug therapy

Substances

  • aflibercept