AzTrials
AzTrials

Age-Related Macular DegenerationBELNCT05220085

Beovu Experience UZ Leuven

An observational study of Age-Related Macular Degeneration, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution
Type of treatment
Injection or infusion
How many people
17 participants
Where
1 siteBelgium
Study dates
1 Dec 2020to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZLEUVEN

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal SolutionDrug

    Intravitreal injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anatomical efficacy of treatment with brolucizumab

    central retinal thickness

    Measured: dec 2020- nov 2021

  2. functional efficacy of treatment with brolucizumab

    best corrected visual acuity

    Measured: dec 2020- nov 2021

Secondary outcomes (1)

  1. Safety of treatment with brolucizumab

    Safety: occurrence of adverse events

    Measured: dec 2020- nov 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start1 Dec 2020
  3. Primary completion1 Nov 2021
  4. Study completion1 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220085
Sponsor's protocol ID
S66240
Acronym
BEL
Status last verified
Jan 2022
First submitted
21 Jan 2022
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30986442

  • 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.

    PubMed 32574761

  • Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, Singerman L. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296-1304. doi: 10.1016/j.ophtha.2017.03.057. Epub 2017 May 24.

    PubMed 28551167

  • Holz FG, Dugel PU, Weissgerber G, Hamilton R, Silva R, Bandello F, Larsen M, Weichselberger A, Wenzel A, Schmidt A, Escher D, Sararols L, Souied E. Single-Chain Antibody Fragment VEGF Inhibitor RTH258 for Neovascular Age-Related Macular Degeneration: A Randomized Controlled Study. Ophthalmology. 2016 May;123(5):1080-9. doi: 10.1016/j.ophtha.2015.12.030. Epub 2016 Feb 20.

    PubMed 26906165

  • Witkin AJ, Hahn P, Murray TG, Arevalo JF, Blinder KJ, Choudhry N, Emerson GG, Goldberg RA, Kim SJ, Pearlman J, Schneider EW, Tabandeh H, Wong RW. Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab. J Vitreoretin Dis. 2020 Jul;4(4):269-279. doi: 10.1177/2474126420930863. Epub 2020 Jul 1.

    PubMed 32789284

  • Jain A, Chea S, Matsumiya W, Halim MS, Yasar C, Kuang G, Sepah YJ, Khanani AM, Do DV, Nguyen QD. Severe vision loss secondary to retinal arteriolar occlusions after multiple intravitreal brolucizumab administrations. Am J Ophthalmol Case Rep. 2020 Apr 2;18:100687. doi: 10.1016/j.ajoc.2020.100687. eCollection 2020 Jun.

    PubMed 32280811

  • Baumal CR, Spaide RF, Vajzovic L, Freund KB, Walter SD, John V, Rich R, Chaudhry N, Lakhanpal RR, Oellers PR, Leveque TK, Rutledge BK, Chittum M, Bacci T, Enriquez AB, Sund NJ, Subong ENP, Albini TA. Retinal Vasculitis and Intraocular Inflammation after Intravitreal Injection of Brolucizumab. Ophthalmology. 2020 Oct;127(10):1345-1359. doi: 10.1016/j.ophtha.2020.04.017. Epub 2020 Apr 25.

    PubMed 32344075

  • Haug SJ, Hien DL, Uludag G, Ngoc TTT, Lajevardi S, Halim MS, Sepah YJ, Do DV, Khanani AM. Retinal arterial occlusive vasculitis following intravitreal brolucizumab administration. Am J Ophthalmol Case Rep. 2020 Mar 31;18:100680. doi: 10.1016/j.ajoc.2020.100680. eCollection 2020 Jun.

    PubMed 32258827

  • 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.

    PubMed 33082532

  • Mones J, Srivastava SK, Jaffe GJ, Tadayoni R, Albini TA, Kaiser PK, Holz FG, Korobelnik JF, Kim IK, Pruente C, Murray TG, Heier JS. Risk of Inflammation, Retinal Vasculitis, and Retinal Occlusion-Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER. Ophthalmology. 2021 Jul;128(7):1050-1059. doi: 10.1016/j.ophtha.2020.11.011. Epub 2020 Nov 15.

    PubMed 33207259

  • Holz FG, Heinz C, Wolf A, Hoerauf H, Pleyer U. [Intraocular inflammation with brolucizumab use : Patient management-diagnosis-therapy]. Ophthalmologe. 2021 Mar;118(3):248-256. doi: 10.1007/s00347-021-01321-8. Epub 2021 Feb 8. German.

    PubMed 33555415

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

anatomical efficacy of treatment with brolucizumab (time frame: dec 2020- nov 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220085, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.

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