Artikel
PULSAR Extension: Clinical improvements maintained over 156 weeks with aflibercept 8 mg in patients with neovascular age-related macular degeneration
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Autoren
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Martin S. Spitzer
- University Medical Center Hamburg-Eppendorf (UKE), Department of Ophthalmology, Hamburg
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Timothy Y. Y. Lai
- The Chinese University of Hong Kong, Department of Ophthalmology & Visual Sciences, Hong Kong SAR, China
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David T. Wong
- University of Toronto, Unity Health Toronto – St. Michael’s Hospital, Toronto, Kanada
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Tien Y. Wong
- Tsinghua University, Tsinghua Medicine, Beijing, China
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Paolo Lanzetta
- University of Udine, Department of Medicine–Ophthalmology, Udine, Italien
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Jean-François Korobelnik
- Université de Bordeaux, INSERM, BPH, UMR1219, Bordeaux, Frankreich
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Frank G. Holz
- University of Bonn, Department of Ophthalmology, Bonn
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Taiji Sakamoto
- Kagoshima University Graduate School of Medical, Department of Ophthalmology, Kagoshima, Japan
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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
| Veröffentlicht: | 13. Mai 2025 |
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Gliederung
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Purpose: To describe long-term data on treatment outcomes with aflibercept 8 mg in patients with neovascular age-related macular degeneration (nAMD) over 156 weeks in the PULSAR Extension.
Methods: In the 96-week, Phase 3 PULSAR trial (NCT04423718), treatment-naïve patients with nAMD were randomly assigned to receive either aflibercept 8 mg every 12 weeks (8q12) or 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), each after 3 initial monthly doses. Patients who completed the main phase of PULSAR through Week 96 were eligible for an optional 1-year open-label extension through Week 156. From Week 96, patients originally assigned to the 2q8 arm were switched to aflibercept 8 mg and immediately assigned a 12-week dosing interval (2 mg→8 mg group), and patients originally assigned to the 8q12 and 8q16 arms continued to receive aflibercept 8 mg at their last assigned dosing interval (8 mg group). From Week 100, dosing intervals were modified in both groups if prespecified disease activity criteria were met, with 8 weeks and 24 weeks as the minimum and maximum dosing intervals allowed, respectively. Endpoints at Week 156 included change from baseline in best-corrected visual acuity (BCVA). All endpoints at Week 156 were exploratory and analyzed descriptively.
Results: At Week 156, the 2 mg→8 mg group (n=208) and 8 mg group (n=417) reported a least-squares mean change from baseline in BCVA of +4.6 and +3.4 letters and central subfield retinal thickness (CRT) of –145 and –148 µm, respectively. On average, BCVA and CRT improvements at Week 96 were largely maintained through Week 156. Among patients who completed Week 156, the last assigned dosing interval was ≥12, ≥16, and 20 weeks in 78%, 42%, and 12% in the 2 mg→8 mg group, respectively, and ≥12, ≥16, ≥20, and 24 weeks in 77%, 58%, 40%, and 24%, respectively, in the 8 mg group. No new safety signals were identified through Week 156.
Conclusions: In the PULSAR Extension, functional and anatomic improvements were largely maintained through Week 156 in the 2 mg→8 mg and 8 mg groups. These findings suggest that patients with treatment-naïve nAMD experience durable improvements with aflibercept 8 mg administered over extended dosing intervals.
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).
