Beovu Experience UZ Leuven

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of neovascular age-related macular degeneration 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution|Intravitreal injection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomical efficacy of treatment with brolucizumab | central retinal thickness | dec 2020- nov 2021 | 
| functional efficacy of treatment with brolucizumab | best corrected visual acuity | dec 2020- nov 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of treatment with brolucizumab | Safety: occurrence of adverse events | dec 2020- nov 2021 |