Introduction <p>The aim of this study was to evaluate the real-world outcomes of brolucizumab use in Japanese patients with neovascular age-related macular degeneration (nAMD).</p> Methods <p>PHEASANT was a retrospective, multicenter, single-arm cohort study. The study included 438 patients, of whom 123 were treatment-naïve and 315 were pre-treated. The primary outcome was retinal fluid (subretinal fluid [SRF] and intraretinal fluid [IRF]) resolution at month 12, with change in visual and retinal anatomy parameters and safety assessed as key secondary outcomes.</p> Results <p>At baseline in the treatment-naïve cohort, 10.1% (<i>n</i> = 7/69) of patients were free of retinal fluid, increasing to 62.3% (<i>n</i> = 43/69) at month 12. In the pre-treated cohort, 14.9% (<i>n</i> = 30/201) of patients were free of retinal fluid at baseline, increasing to 43.8% (<i>n</i> = 88/201) at month 12. The median (interquartile range [IQR]) injection interval for pre-treated patients at month 12 was extended by 21 (7.0–35.0) days. The overall intraocular inflammation rate (including the rate of retinal vasculitis/retinal occlusive vasculitis of 0.46% [2/438]) was 8.4% (<i>n</i> = 37/438).</p> Conclusion <p>In a real-world clinical setting, brolucizumab was effective at drying the retina in treatment-naïve and pre-treated Japanese nAMD patients and therefore has the potential to reduce the treatment burden by prolonging injection intervals. Safety outcomes support the overall favorable benefit/risk profile of brolucizumab.</p> ClinicalTrials.gov Identifier <p>NCT06699914.</p>

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Real-World Outcomes of Brolucizumab Treatment in Japanese Patients with Neovascular Age-Related Macular Degeneration: A 12-Month, Multicenter Study

  • Masayuki Ohnaka,
  • Yoichi Sakurada,
  • Atsushi Hayashi,
  • Kazuaki Kadonosono,
  • Hitoshi Ohno,
  • Ryusaburo Mori,
  • Hidetaka Matsumoto,
  • Ippei Nagamori,
  • Yuki Murata,
  • Tina Maio-Twofoot,
  • Helene Karcher,
  • Hidenori Takahashi

摘要

Introduction

The aim of this study was to evaluate the real-world outcomes of brolucizumab use in Japanese patients with neovascular age-related macular degeneration (nAMD).

Methods

PHEASANT was a retrospective, multicenter, single-arm cohort study. The study included 438 patients, of whom 123 were treatment-naïve and 315 were pre-treated. The primary outcome was retinal fluid (subretinal fluid [SRF] and intraretinal fluid [IRF]) resolution at month 12, with change in visual and retinal anatomy parameters and safety assessed as key secondary outcomes.

Results

At baseline in the treatment-naïve cohort, 10.1% (n = 7/69) of patients were free of retinal fluid, increasing to 62.3% (n = 43/69) at month 12. In the pre-treated cohort, 14.9% (n = 30/201) of patients were free of retinal fluid at baseline, increasing to 43.8% (n = 88/201) at month 12. The median (interquartile range [IQR]) injection interval for pre-treated patients at month 12 was extended by 21 (7.0–35.0) days. The overall intraocular inflammation rate (including the rate of retinal vasculitis/retinal occlusive vasculitis of 0.46% [2/438]) was 8.4% (n = 37/438).

Conclusion

In a real-world clinical setting, brolucizumab was effective at drying the retina in treatment-naïve and pre-treated Japanese nAMD patients and therefore has the potential to reduce the treatment burden by prolonging injection intervals. Safety outcomes support the overall favorable benefit/risk profile of brolucizumab.

ClinicalTrials.gov Identifier

NCT06699914.