NCT05220085

Beovu Experience UZ Leuven

Real-life Beovu Experience at UZ Leuven for the Treatment of Exudative Neovascular Age-related Macular Degeneration

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 17 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Reporting early real-world clinical data of consecutive patients on the use of Beovu® (brolucizumab) intravitreal injections in patients with neovascular age-related macular degeneration.

Detailed description

Brolucizumab (Beovu, Novartis, Basel, Switzerland) is the newest anti-vascular endothelial growth factor (anti-VEGF) drug. It received FDA approval for the treatment of neovascular age-related macular degeneration (nAMD) in October 2019 followed by EMA approval in February 2020. Brolucizumab received marketing approval based on the two pivotal phase 3 clinical trials - HAWK and HARRIER - with a q8/q12 week dosing regimen. Potential benefits of brolucizumab are assumed to be related to its low molecular weight with subsequent better tissue penetration as well as higher molar concentration. This could improve the treatment durability and lower the burden for patients and caregivers when dealing with repetitive intravitreal treatments and monitoring visits over a long period of time in a chronic disease. However, safety signals have been reported in both RCTs and post-marketing reports, which included the occurrence of intraocular inflammation (IOI) and retinal vasculitis with or without occlusion. In this study we want to share our early results and experience with Bolucizumab in UZ Leuven. By retrospective analysis of a cohort of 17 patients treated with Brolucizumab, we evaluate the efficacy of the drug as well as the occurrence of adverse-events, especially intra-ocular inflammation and vasculitis.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution	Intravitreal injection

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-11-01
• Completion: 2022-04-01
• First posted: 2022-02-02
• Last updated: 2022-02-02

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study