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Clinical trials for brolucizumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44410   clinical trials with a EudraCT protocol, of which   7419   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: brolucizumab. Displaying page 1 of 1.
    EudraCT Number: 2017-003960-11 Sponsor Protocol Number: CRTH258B2302 Start Date*: 2018-08-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Dia...
    Medical condition: diabetic macular edema
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) LT (Completed) SK (Completed) SE (Completed) BE (Completed) DK (Completed) HU (Completed) CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001031-31 Sponsor Protocol Number: CRTH258BDE01 Start Date*: 2019-10-10
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A comperative BouBle Masked, Two-Arm, Randomized, MUlticenter, Phase IIb Study analyZing the Efficacy and Safety of BroluciZumab versus Aflibercept in Paients with Visual ImpaiRment due to Diabetic...
    Medical condition: diabetic macular edema
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004742-23 Sponsor Protocol Number: CRTH258B2301 Start Date*: 2018-09-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A Two-Year, Three-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to D...
    Medical condition: diabetic macular edema
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) AT (Completed) ES (Ongoing) PT (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-001004-37 Sponsor Protocol Number: CRTH258B2305 Start Date*: 2019-07-26
    Sponsor Name:Novartis Pharma AG
    Full Title: A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab every 4 weeks versus Aflibercept every 4 weeks in Adult Patients with Vis...
    Medical condition: Diabetic Macular Edema
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-004767-53 Sponsor Protocol Number: CRTH258ADE01 Start Date*: 2020-12-16
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A 52-week, two arm, randomized, open-label, multicenter study assessing the efficacy and safety of two different brolucizumab 6 mg dosing regimens for patients with suboptimal anatomically controll...
    Medical condition: neovascular age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002349-40 Sponsor Protocol Number: CRTH258A2303E1 Start Date*: 2020-11-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A 56-week phase IIIb/IV, open-label, one-arm extension study to assess the efficacy and safety of brolucizumab 6mg in a Treat-to-Control regimen with maximum treatment intervals up to 20 weeks for ...
    Medical condition: neovascular Age-related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) PT (Completed) CZ (Completed) SE (Completed) BE (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001788-21 Sponsor Protocol Number: CRTH258C2302 Start Date*: 2019-06-06
    Sponsor Name:Novartis Pharma AG
    Full Title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multi center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment du...
    Medical condition: Central retinal vein occlusion
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10007972 Central retinal vein occlusion LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Prematurely Ended) HU (Completed) NL (Prematurely Ended) GR (Prematurely Ended) FI (Completed) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002452-20 Sponsor Protocol Number: CRTH258AIT04 Start Date*: 2021-01-13
    Sponsor Name:NOVARTIS FARMA S.P.A.
    Full Title: One year, single arm, open label, multicenter, phase IV study using multimodal imaging to guide disease activity assessment through innovative early predictive anatomical biomarkers of fluid resolu...
    Medical condition: Age-related neovascular macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000716-28 Sponsor Protocol Number: CRTH258A2303 Start Date*: 2019-09-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A 64-week, two-arm, randomized, double-masked, multi-center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in pa...
    Medical condition: neovascular age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) IT (Completed) CZ (Completed) SE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) BE (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-004145-33 Sponsor Protocol Number: CRTH258AFR03 Start Date*: 2020-04-07
    Sponsor Name:Novartis Pharma S.A.S
    Full Title: A one-year, single-arm, open-label, multicenter study assessing the effect of brolucizumab on disease control in adult patients with suboptimal anatomically controlled neovascular age-related macul...
    Medical condition: neovascular age-related macular degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001842-33 Sponsor Protocol Number: CRTH258C2301 Start Date*: 2019-06-14
    Sponsor Name:Novartis Pharma AG
    Full Title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multi center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment du...
    Medical condition: Branch retinal vein occlusion
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10038907 Retinal vein occlusion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) DK (Prematurely Ended) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001058-73 Sponsor Protocol Number: BEY-RAP.V1.0 Start Date*: 2021-06-23
    Sponsor Name:Fakultní nemocnice Královské Vinohrady
    Full Title: Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation - Prospective Randomised Study
    Medical condition: Retinal angiomatous proliferation form of neovascular age related macular degeneration (AMD).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003133-42 Sponsor Protocol Number: 1672_2019 Start Date*: 2020-02-14
    Sponsor Name:Medical University of Vienna, Department of Ophthalmology and Optometry
    Full Title: Personalized treatment aided by automated analysis of fluid in active neovascular age-related macular degeneration (nAMD) in a prospective, multicenter, randomized study
    Medical condition: Nevoascular age related macular degneration (nAMD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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