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Completed

NCT Number: NCT05526729

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.

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Key information

Conditions

Diabetic Macular Edema

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagakute, Aichi-ken, Japan

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About this study

This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.

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

In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied.

  • Date of last Beovu dose + 90 days* in primary treated eye > Week 52: up to Week 52
  • Date of last Beovu dose + 90 days* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days *90 days: to collect as much data as possible considering clinical effects

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 the start of treatment with Beovu
  • Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema

Exclusion criteria

  • Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu

Treatment and study plan

Beovu

Other

Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.

Other names: Brolucizumab

Primary outcomes

  1. Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected.

    Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion

  2. Proportions of patients with adverse events in the eyes on therapy during the observation period

    Time frame: Up to 52 weeks

    Proportions of patients with adverse events in the eyes on therapy during the observation period was collected

  3. Proportion of patients with systemic adverse events during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected

Secondary outcomes

  1. Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period was collected

  2. Proportion of patients with systemic SAEs and adverse reactions during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with systemic (non-ocular) SAEs and adverse reactions during the observation period was collected

  3. Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period was collected.

    Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion

  4. Incidences of adverse events by risk factor of the safety specifications

    Time frame: Up to 52 weeks

    Incidences of adverse events by risk factor of the safety specifications (primary treated eyes only) was collected.

    Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion

  5. Proportion of patients with VA worsening during the observation period

    Time frame: Up to 52 weeks

    Proportion of patients with decimal VA worsening during the observation period was calculated.

    VA was measured in best corrected visual acuity (BCVA). BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses

  6. Proportion of patients by administration status in the induction and maintenance phase during the observation period

    Time frame: Up to 52 weeks

    Number of patients by administration status (yes/no) in the induction and maintenance phase during the observation period was collected

  7. Proportion of patients by treated eye in the induction and maintenance phase during the observation period

    Time frame: Up to 52 weeks

    Number of patients by treated eye (right eye/left eye) in the induction and maintenance phase during the observation period was collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2022
Registry last updated
Jun 13, 2025

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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