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Completed

NCT Number: NCT04632056

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

This study was 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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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

However, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was 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 was to be monitored for adverse events until 30 days after the last dose of this drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beovu

Drug

There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.

Other names: Brolucizumab

Primary outcomes

  1. Number of patients with adverse events in the eyes on therapy

    Time frame: 52 weeks

    Number of patients with adverse events (AEs) in the eyes on therapy were reported

  2. Number of patients with adverse events in other parts of the body (non-ocular)

    Time frame: 52 weeks

    Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported

Secondary outcomes

  1. Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy

    Time frame: 52 weeks

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.

  2. Number of patients with SAEs and ADRs in other parts of the body (non-ocular)

    Time frame: 52 weeks

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.

  3. Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications

    Time frame: 52 weeks

    The following events were chosen as the safety specifications for this study that should be investigated:

    • Intraocular inflammation
    • Endophthalmitis
    • Increased intraocular pressure
    • Retinal pigment epithelial tear
    • Retinal detachment and retinal tear
    • Retinal artery embolic events
    • Non-ocular arterial thromboembolic events
    • Retinal vasculitis and retinal vascular occlusion

  4. Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)

    Time frame: 52 weeks

    Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) were reported

  5. Proportion of patients with visual acuity (VA) worsening

    Time frame: 52 weeks

    Visual acuity commonly refers to the clarity of vision

  6. Data on Beovu administration in the induction phase and maintenance phase

    Time frame: 52 weeks

    For data on Beovu administration (dosing duration, dosing frequency) in the primary treated eye and the secondary primary eyes in the safety analysis set, summary statistics were calculated respectively. The same calculation applied to data on administration respectively for the induction period and the maintenance period.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2020
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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