Clinical trial NCT05220085: Beovu Experience UZ Leuven
Official title: Real-life Beovu Experience at UZ Leuven for the Treatment of Exudative Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants eligible for inclusion in this Study must meet all of the following 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

List details under which a participant is considered unsuitable for inclusion in the Study.

Participants eligible for this Study must not meet any of the following 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: anatomical efficacy of treatment with brolucizumab
timeFrame: dec 2020- nov 2021
measure: functional efficacy of treatment with brolucizumab
timeFrame: dec 2020- nov 2021
Secondary outcomes:
measure: Safety of treatment with brolucizumab
timeFrame: dec 2020- nov 2021
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLEUVEN
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Julie Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dugel PU, Koh A, Ogura Y, Jaffe GJ, Schmidt-Erfurth U, Brown DM, Gomes AV, Warburton J, Weichselberger A, Holz FG; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020 Jan;127(1):72-84. doi: 10.1016/j.ophtha.2019.04.017. Epub 2019 Apr 12.
citation: Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, Jaffe GJ, Tadayoni R, Schmidt-Erfurth U, Holz FG. HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2021 Jan;128(1):89-99. doi: 10.1016/j.ophtha.2020.06.028. Epub 2020 Jun 20.
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citation: Sharma A, Kumar N, Parachuri N, Singh S, Bandello F, Kuppermann BD, Loewenstein A. Brolucizumab-related retinal vasculitis: emerging disconnect between clinical trials and real world. Eye (Lond). 2021 May;35(5):1292-1294. doi: 10.1038/s41433-020-01227-w. Epub 2020 Oct 20. No abstract available.
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