Abstract

The present study aimed to determine the efficacy and safety of pro re nata (PRN) intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) without a loading dose in the real-world setting. The PROBE study (Pro Re Nata Brolucizumab for Exudative AMD) is a retrospective, observational, multicentric study that included 27 treatment-naïve patients (27 eyes) with neovascular AMD who received PRN brolucizumab therapy with the treatment interval being at least 8 weeks, should the need for a second consecutive injection arise. The primary outcome measure was changed to best-corrected visual acuity (BCVA) over time. Secondary outcome measures included the determination of change in central subfield thickness (CST) and complications. The mean follow-up was 11.2 ± 1.2 months. The mean baseline and final BCVA were 57.4 ± 4.5 letters and 65.3 ± 3.12 letters, respectively (p = 0.014). The mean gain in letters at the end of follow-up was 7.8 ± 3.5 letters. There was a significant decrease in CST at the end of the follow-up period (p = 0.013). Patients received a mean of 2.2 ± 0.9 injections (in addition to the first mandatory injection) during the follow-up period. There were no adverse events noted. In conclusion, initial PRN brolucizumab for exudative AMD without a loading dose demonstrated significant visual improvement and no adverse events.

Highlights

  • Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly in industrialized countries

  • Since the advent of anti-vascular endothelial growth factor (VEGF) therapy, numerous studies have demonstrated that monthly injections provide high and sustained visual gain, but were found to be rather impractical and perhaps even unsustainable in the long term

  • Monés et al have looked at the possibility of combining fixed interval and pro re nata (PRN) injections for neovascular age-related macular degeneration (nAMD), thereby reducing the total number of requisite treatments while maintaining visual acuity gains comparable to historical evidence published for monthly injections [16]

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Summary

Introduction

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly in industrialized countries. Anti-VEGF agents have revolutionized therapy for neovascular age-related macular degeneration (nAMD) [1,2]. These molecules provide excellent results when injected every month, visual loss is observed when the treatment is given less frequently [3]. A decade’s experience of anti-VEGF therapy has taught us to minimize therapy and to maximize visual gains, thereby sparing patients the physical and psychological burden of multiple treatment visits [4] and the potential threat of geographic atrophy ( this rarely manifests, if ever) [5]. An alternative approach would be to look at more potent and durable formulations that obviate the need for intense therapy

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