Brolucizumab for Neovascular Age-Related Macular Degeneration (BEL Study)

Abstract

Purpose

This retrospective observational study reports early results on a cohort of neovascular age-related macular degeneration (nAMD) patients switched to brolucizumab, a recently approved anti-vascular endothelial growth factor (anti-VEGF).

Patients and Methods

We evaluated best-corrected visual acuity (BCVA), treatment interval, central subfield retinal thickness (CST) and the presence of intra-retinal (IRF), subretinal (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid on optical coherence tomography (OCT). Concurrently, patients were carefully examined for signs of intra-ocular inflammation (IOI) and other adverse events.

Results

Seventeen patients (19 eyes) were included. The difference in BCVA at baseline compared to the last examination following brolucizumab injection was not statistically significant (Wilcoxon signed-rank test, p=0.247). Mean CST decrease was −5.16 ±48.28 µm (p=0.647). A morphological improvement in IRF was observed in four eyes, with a complete resolution in 50% (n=2) and a decrease in 50% (n=2). Regarding SRF (total n=15), resolution was seen in 46.67% (n=7), decrease in 26.67% (n=4) and stabilization in 13.33% (n=2). Increase in SRF was observed in 13.33% (n=2). Of 14 eyes with sub-RPE fluid, 7.14% (n=1) demonstrated a resolution, 42.86% (n=6) a decrease, 50% (n=7) a stabilization and none an increase in fluid. Mean treatment interval was increased by 4.08 ±1.40 weeks (p<0.001). Treatment was discontinued in seven eyes (41.18%), including four cases due to IOI. In all four cases, inflammation was mild and resolved under corticosteroid treatment. No cases of vasculitis were observed.

Conclusion

This study provides additional data suggesting that brolucizumab is a beneficial alternative for patients refractory to other anti-VEGF therapies. It can provide a morphological reduction in fluid and prolong the treatment interval, while maintaining a stable BCVA and CST. However, as a higher occurrence of IOI is probable, patients should be informed, selected and monitored carefully. Signs of inflammation should be detected early and treated promptly.

Keywords:

• macular degeneration
• vascular endothelial growth factor A
• intravitreal injections
• treatment outcome
• inflammation

Data Sharing Statement

All data acquired during this study are included in the article and its online Supplementary Material. Further inquiries can be administered to the corresponding author.

Statement of Ethics

The study protocol was reviewed and approved by Ethics Committee Research UZ/KU Leuven, approval number S66240. As this was a retrospective study, the committee decided that written informed consent was not needed. The study complied with the tenets of the Declaration of Helsinki.

Acknowledgments

Novartis Pharma has provided the brolucizumab samples used in this study. There was no additional funding or role in this study. The company had no input into the content of this article.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

J.J. is a consultant for Novartis, Bayer, Roche and MONA.health. F.P. is a consultant for Novartis, Bayer, AbbVie, Horus Pharma and MONA.health. The authors report no other conflicts of interest in this work.