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Background <p>The phase&#xa0;3 clinical trial PULSAR demonstrated extended treatment intervals with aflibercept 8 mg in treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) in a&#xa0;large proportion of the cohort, with good drug safety. Early clinical experience in real-world settings confirmed the efficacy in both treatment-naïve and pretreated patients but no data on longer observation periods are available yet.</p> Objective <p>The aim of the study was to investigate the efficacy, treatment frequency and tolerability of aflibercept 8 mg over a&#xa0;period of 12&#xa0;months in a&#xa0;group of pretreated nAMD patients.</p> Material and methods <p>A&#xa0;retrospective study of 73&#xa0;eyes with nAMD and pretreatment with anti-VEGF switched to aflibercept 8 mg. Eyes were initially uploaded with 3&#xa0;monthly intravitreal injections (IVI), followed by a&#xa0;pro re nata (PRN) regimen. Outcome parameters included visual acuity development and central retinal thickness (CSRT) after upload and 12&#xa0;months, treatment frequency in the year before and after switching to aflibercept 8 mg, and the overall tolerability of the drug.</p> Results <p>Of the initial 73&#xa0;eyes, 27&#xa0;eyes (37.0%) were still receiving aflibercept 8 mg after 12&#xa0;months. In these eyes CSRT was reduced from 387.9 ± 138.4 µm initially to 305.5 ± 93.2 µm after upload and 328.9 ± 105.6 µm after 12&#xa0;months (<i>p</i> &lt; 0.001). Visual acuity remained stable (<i>p</i> &gt; 0.05). Compared to the year prior to switching, the injection frequency was reduced from 8.2 ± 2.1 to 6.9 ± 1.0 IVIs (<i>p</i> &lt; 0.005). During the observation period, a&#xa0;total of 5&#xa0;eyes (6.8%) developed noninfectious intraocular inflammation (IOI), with all cases completely regressing with topical treatment.</p> Conclusion <p>These results confirm a&#xa0;good efficacy of aflibercept 8 mg for the treatment of nAMD with reduced injection frequency after 12&#xa0;months of treatment in a&#xa0;portion of pretreated eyes that were often previously refractory to treatment. Longer observation intervals and experience with other treatment regimens are necessary to confirm this observation.</p>

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Real-World-Erfahrungen mit Aflibercept 8 mg zur Behandlung der neovaskulären altersbedingten Makuladegeneration nach 12 Monaten

  • 期刊论文

  • 发表日期：

    2026年7月3日

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  • Michael Grün,
  • Kai Rothaus,
  • Alexander Beger,
  • Carla Winter,
  • Albrecht Lommatzsch,
  • Henrik Faatz

摘要

Background

The phase 3 clinical trial PULSAR demonstrated extended treatment intervals with aflibercept 8 mg in treatment-naïve eyes with neovascular age-related macular degeneration (nAMD) in a large proportion of the cohort, with good drug safety. Early clinical experience in real-world settings confirmed the efficacy in both treatment-naïve and pretreated patients but no data on longer observation periods are available yet.

Objective

The aim of the study was to investigate the efficacy, treatment frequency and tolerability of aflibercept 8 mg over a period of 12 months in a group of pretreated nAMD patients.

Material and methods

A retrospective study of 73 eyes with nAMD and pretreatment with anti-VEGF switched to aflibercept 8 mg. Eyes were initially uploaded with 3 monthly intravitreal injections (IVI), followed by a pro re nata (PRN) regimen. Outcome parameters included visual acuity development and central retinal thickness (CSRT) after upload and 12 months, treatment frequency in the year before and after switching to aflibercept 8 mg, and the overall tolerability of the drug.

Results

Of the initial 73 eyes, 27 eyes (37.0%) were still receiving aflibercept 8 mg after 12 months. In these eyes CSRT was reduced from 387.9 ± 138.4 µm initially to 305.5 ± 93.2 µm after upload and 328.9 ± 105.6 µm after 12 months (p < 0.001). Visual acuity remained stable (p > 0.05). Compared to the year prior to switching, the injection frequency was reduced from 8.2 ± 2.1 to 6.9 ± 1.0 IVIs (p < 0.005). During the observation period, a total of 5 eyes (6.8%) developed noninfectious intraocular inflammation (IOI), with all cases completely regressing with topical treatment.

Conclusion

These results confirm a good efficacy of aflibercept 8 mg for the treatment of nAMD with reduced injection frequency after 12 months of treatment in a portion of pretreated eyes that were often previously refractory to treatment. Longer observation intervals and experience with other treatment regimens are necessary to confirm this observation.