Beovu Experience UZ Leuven | NCT05220085

Studies
Beovu Experience UZ Leuven

NCT05220085

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Feb 2, 2022Actual

Enrollment

17Estimated

Phase

Not provided

Conditions

Age-Related Macular Degeneration

Interventions

Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Jan 21, 2022

First Submission Date that Met QC Criteria

Jan 21, 2022

First Posted Date

Feb 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2022

Last Update Posted Date

Feb 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Estimated

Name	Type	Description	Arm Group Labels	Other Names
Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution	Drug	Intravitreal injection

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants eligible for inclusion in this Study must meet all of the following 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

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:

Any form of previous intraocular inflammation
Any form of previous inflammatory reaction after anti-VEGF treatment
Functionally monophthalmic patients
Any sign of active intraocular inflammation

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Julie Jacob, MD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UZLEUVEN		Leuven		3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30986442	Background	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.
32574761

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases