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

Novartis

Status: Completed

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Beovu

Study type: Observational

Funder types: Industry

Identifiers

NCT04632056

CRTH258A1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 329 patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection

2. 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

1. 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

Trial design

329 participants in 1 patient group

Beovu

Description:

Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks

Treatment:

Drug: Beovu