Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
17 participants
OBSERVATIONAL
2020-12-01
2022-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Brolucizumab Ophthalmic Dbll 6 Mg/0.05 mL Intravitreal Solution
Intravitreal injection
Eligibility Criteria
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Inclusion Criteria
2. Partial response on current anti-VEGF treatment or unability to prolong the treatment interval beyond 6 or 8 weeks
Exclusion Criteria
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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JulieJacob
prof.dr.Julie Jacob
Principal Investigators
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Julie Jacob, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZLEUVEN
Leuven, , Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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S66240
Identifier Type: -
Identifier Source: org_study_id
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