Introduction <p>This study reports the 1-year efficacy of aflibercept 8&#xa0;mg (afl8) in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD).</p> Methods <p>An observational, retrospective case series from nine centers of the Swiss Retina Research Network including treatment-naïve eyes with nAMD started on intravitreal afl8. Changes in visual acuity (VA), macular thickness, pigment epithelial detachment (PED) height, and retinal fluids were evaluated over 12&#xa0;months and compared with baseline. Treatment intervals and safety data were recorded along with subgroup analyses based on macular neovascularization type, loading-phase completion, and treatment regimen.</p> Results <p>A total of 91 eyes met the inclusion criteria. After 1 year of treatment, VA changed by + 1.0 ± 13.2 letters (<i>p</i> = 0.018), mean CST changed by −110.0 ± 130.9&#xa0;µm (<i>p</i> &lt; 0.001), and mean PED height changed by −71.2 ± 104.8&#xa0;µm (<i>p</i> &lt; 0.001). After 12&#xa0;months, 66.2% of eyes demonstrated a complete absence of macular fluids. Mean treatment interval was 13.9 ± 7.9&#xa0;weeks, with 56.1% of eyes being extended to ≥ 12&#xa0;weeks with an anatomy-driven approach. No functional or anatomical differences were observed between eyes receiving a clean loading phase and in terms of different macular neovascularization (MNV) subtypes. Two adverse events were observed.</p> Conclusions <p>The first 1-year real-world experience with afl8 in patients with nAMD revealed a robust anatomical response but only a variable and limited visual gain over 12&#xa0;months due to a ceiling effect. Our findings confirm the fast and sustained macular drying reported from clinical trials, allowing for extended treatment intervals without compromising safety and efficacy.</p>

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One-Year Real-World Outcomes of Aflibercept 8 mg in Treatment-Naïve Neovascular Age-Related Macular Degeneration: A Swiss Retina Research Network Report

  • Gabriela Grimaldi,
  • Nicolò Bartolomeo,
  • Justus G. Garweg,
  • Isabel B. Pfister,
  • Christin Schild,
  • Arianna Peyla,
  • Anne Tillmann,
  • Eva Cristina De Oliveira Figueiredo,
  • Tahm Spitznagel,
  • Alice M. Kitay,
  • Felix Gabathuler,
  • Sandrine Zweifel,
  • Malaika Mihal Kurz-Levin,
  • Andreas Ebneter,
  • Gábor Márk Somfai,
  • Chiara M. Eandi,
  • Marion R. Munk,
  • Aude Ambresin,
  • Moreno Menghini

摘要

Introduction

This study reports the 1-year efficacy of aflibercept 8 mg (afl8) in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD).

Methods

An observational, retrospective case series from nine centers of the Swiss Retina Research Network including treatment-naïve eyes with nAMD started on intravitreal afl8. Changes in visual acuity (VA), macular thickness, pigment epithelial detachment (PED) height, and retinal fluids were evaluated over 12 months and compared with baseline. Treatment intervals and safety data were recorded along with subgroup analyses based on macular neovascularization type, loading-phase completion, and treatment regimen.

Results

A total of 91 eyes met the inclusion criteria. After 1 year of treatment, VA changed by + 1.0 ± 13.2 letters (p = 0.018), mean CST changed by −110.0 ± 130.9 µm (p < 0.001), and mean PED height changed by −71.2 ± 104.8 µm (p < 0.001). After 12 months, 66.2% of eyes demonstrated a complete absence of macular fluids. Mean treatment interval was 13.9 ± 7.9 weeks, with 56.1% of eyes being extended to ≥ 12 weeks with an anatomy-driven approach. No functional or anatomical differences were observed between eyes receiving a clean loading phase and in terms of different macular neovascularization (MNV) subtypes. Two adverse events were observed.

Conclusions

The first 1-year real-world experience with afl8 in patients with nAMD revealed a robust anatomical response but only a variable and limited visual gain over 12 months due to a ceiling effect. Our findings confirm the fast and sustained macular drying reported from clinical trials, allowing for extended treatment intervals without compromising safety and efficacy.