Regulatory Post-Marketing Surveillance Study for Brolucizumab

Novartis

Status: Enrolling

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Other: brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT04985487

CRTH258AKR01

Details and patient eligibility

About

This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.

Full description

The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)

Exclusion criteria

1. Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.
2. Patients participating in other investigational drug trial

Trial design

3,000 participants in 1 patient group

Brolucizumab

Description:

Patients prescribed with brolucizumab in the approved indication

Treatment:

Other: brolucizumab