NCT05220085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 21, 2022

Last Update Submit

January 21, 2022

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Safety of treatment with brolucizumab

    dec 2020- nov 2021

Interventions

Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal SolutionDRUG

Intravitreal injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLEUVEN

Leuven, 3000, Belgium

Location

Related Publications (11)

  • 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.

    PMID: 30986442BACKGROUND

  • 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.

    PMID: 32574761BACKGROUND

  • 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.

    PMID: 28551167BACKGROUND

  • 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.

    PMID: 26906165BACKGROUND

  • 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.

    PMID: 32789284BACKGROUND

  • 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.

    PMID: 32280811BACKGROUND

  • 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.

    PMID: 32344075BACKGROUND

  • 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.

    PMID: 32258827BACKGROUND

  • 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.

    PMID: 33082532BACKGROUND

  • 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.

    PMID: 33207259BACKGROUND

  • 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.

    PMID: 33555415BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Julie Jacob, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.dr.Julie Jacob

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 2, 2022

Study Start

December 1, 2020

Primary Completion

November 1, 2021

Study Completion

April 1, 2022

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)