Beovu Experience UZ Leuven (BEL)

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution

Study type: Observational

Funder types: Other

Identifiers

NCT05220085

S66240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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