Regulatory Post-Marketing Surveillance Study for Brolucizumab

Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)

ClinicalTrials.gov Identifier: NCT04985487

Novartis Reference Number: CRTH258AKR01

Last Update: Sep 28, 2021

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Neovascular Age-related Macular Degeneration
Phase 
Not Given
Overall status 
Recruiting
Start date 
Aug 18, 2021
Completion date 
Jun 14, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Other
brolucizumab
Prospective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
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:

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.
Patients participating in other investigational drug trial

Study Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]