Artikel
Greater and more durable fluid resolution with aflibercept 8 mg versus aflibercept 2 mg in the PULSAR trial: A 96-week post-hoc analysis
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Autoren
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Helmut Sachs
- Medizinische Universität Lausitz, Carl Thiem, Cottbus
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Richard Gale
- York and Scarborough Teaching Hospital NHS Foundation Trust, York, Vereinigtes Königreich
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Aude Ambresin
- Swiss Visio Montchoisi, Lausanne, Schweiz
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Marion Munk
- Augenarzt-Praxisgemeinschaft Gutblick AG, Freienbach, Schweiz
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Praveen J. Patel
- Moorfields Eye Hospital, NHS Foundation Trust, NIHR Moorfields Biomedical Research Centre, London, Vereinigtes Königreich
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Paolo Lanzetta
- Ophthalmology, University of Udine, and IEMO, Department of Medicine, Udine, Italien
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Jean-François Korobelnik
- University of Bordeaux, INSERM, UMR1219, Bordeaux Population Health Research Center, Bordeaux, Frankreich
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Sobha Sivaprasad
- Moorfields Eye Hospital, NHS Foundation Trust, NIHR Moorfields Biomedical Research Centre, London, Vereinigtes Königreich
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Sergio Leal
- Bayer Consumer Care AG, Pharmaceuticals, Basel, Schweiz
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Xin Zhang
- Bayer Consumer Care AG, Pharmaceuticals, Basel, Schweiz
| Veröffentlicht: | 13. Mai 2025 |
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Gliederung
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Purpose: To evaluate fluid resolution with aflibercept 8 mg compared with aflibercept 2 mg at matched timepoints.
Methods: PULSAR was a double-masked, 96-week, phase 3 trial; patients with neovascular age-related macular degeneration (nAMD) were randomized 1:1:1 to receive aflibercept 2 mg every 8 weeks, or aflibercept 8 mg every 12 or 16 weeks, each after 3 monthly injections. Eligibility criteria included subfoveal choroidal neovascularization secondary to nAMD and the presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the central subfield of the study eye. Due to the different dosing intervals in the aflibercept 8 mg and 2 mg arms after the initial monthly injections, a post-hoc matched timepoint analysis was conducted such that outcomes could be compared between patients in each treatment arm who had received the same number of active injections. The proportion of patients with fluid resolution (no IRF and no SRF in the central subfield) and change in central subfield retinal thickness (CRT) from baseline were evaluated 8 weeks after each of the third-to-seventh matched injection timepoints. The relative percentage difference in the proportion of patients with fluid resolution between treatment arms at each timepoint was calculated as the difference in absolute percentages between the aflibercept 2 mg and 8 mg group divided by the percentages in the 2 mg group.
Results: A greater proportion of patients were fluid-free at each assessment 8 weeks after the third-to-seventh active injections in the aflibercept 8 mg group versus the 2 mg group (60%–68% versus 51%–57%), with a relative percentage difference of 14%–23% across visits. Reductions in CRT from baseline 8 weeks after the third-to-seventh matched injections were numerically greater in the aflibercept 8 mg group (ranging from –127 to –145 µm) than the 2 mg group (ranging from –114 to –126 µm).
Conclusions: A greater proportion of patients receiving aflibercept 8 mg had fluid resolution, and greater reductions in CRT were observed in these patients compared with those receiving 2 mg when assessed 8 weeks after each active injection. This supports more durable improvements in anatomic outcomes with aflibercept 8 mg than with 2 mg.
This abstract has been recently submitted and will be presented at the 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).
