A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    300
  • sponsor
    Novartis Pharmaceuticals
Updated on 26 September 2021

Summary

This study is a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.

Description

The observational period will be 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.

However, if brolucizumab is discontinued in the primary treated eye and if the treatment is discontinued less than 52 weeks observation period, the observation period will be up to 90 days after the last dose of this drug. This is set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient should be monitored for adverse events until 30 days after the last dose of this drug

Details
Condition Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment Beovu
Clinical Study IdentifierNCT04632056
SponsorNovartis Pharmaceuticals
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection
Patients using Beovu kit for intravitreal injection for the first time for the following indication
Indication: age-related macular degeneration with subfoveal choroidal neovascularization

Exclusion Criteria

Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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