Beovu Experience UZ Leuven

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT05220085
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-11-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Diagnosis of neovascular age-related macular degeneration
2. Partial response on current anti-VEGF treatment or unability to prolong the treatment interval beyond 6 or 8 weeks

Exclusion Criteria

• 1. Any form of previous intraocular inflammation 2. Any form of previous inflammatory reaction after anti-VEGF treatment 3. Functionally monophthalmic patients 4. Any sign of active intraocular inflammation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anatomical efficacy of treatment with brolucizumab	dec 2020- nov 2021	central retinal thickness
functional efficacy of treatment with brolucizumab	dec 2020- nov 2021	best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
Safety of treatment with brolucizumab	dec 2020- nov 2021	Safety: occurrence of adverse events

Trial Locations

Locations (1)

UZLEUVEN; 🇧🇪 Leuven, Belgium