NCT04632056

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 329 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

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

Timeline

• Start date: 2020-11-16
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2020-11-17
• Last updated: 2023-11-14

Locations

67 sites across 1 country: Japan