Last Update: Jan 14, 2025
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
ClinicalTrials.gov Identifier:
NCT04985487
Novartis Reference Number:CRTH258AKR01
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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. 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.

Neovascular Age-related Macular Degeneration
Recruiting
3000
Aug 18, 2021
Jun 14, 2026
All
18 Years - 100 Years (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:

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

Novartis Investigative Site

Recruiting

Jeju City,63206,South Korea

Novartis Investigative Site

Recruiting

Taegu,41944,South Korea

Novartis Investigative Site

Recruiting

Seoul,07441,South Korea

Novartis Investigative Site

Recruiting

Seoul,07301,South Korea

Novartis Investigative Site

Recruiting

Seoul,06351,South Korea

Novartis Investigative Site

Recruiting

Seoul,06273,South Korea

Novartis Investigative Site

Recruiting

Seoul,05368,South Korea

Novartis Investigative Site

Recruiting

Seoul,04763,South Korea

Novartis Investigative Site

Recruiting

Seoul,04401,South Korea

Novartis Investigative Site

Recruiting

Seoul,03722,South Korea

Novartis Investigative Site

Recruiting

Seoul,03080,South Korea

Novartis Investigative Site

Recruiting

Seoul,02841,South Korea

Novartis Investigative Site

Recruiting

Seoul,01000,South Korea

Novartis Investigative Site

Recruiting

Pusan,614 735,South Korea

Novartis Investigative Site

Recruiting

Daegu,Dalseo Gu,42602,South Korea

Novartis Investigative Site

Recruiting

Incheon,22332,South Korea

Novartis Investigative Site

Recruiting

Gwangju,61932,South Korea

Novartis Investigative Site

Recruiting

Gwangju,61489,South Korea

Novartis Investigative Site

Recruiting

Daegu,705703,South Korea

Novartis Investigative Site

Recruiting

Daegu,705 718,South Korea

Novartis Investigative Site

Recruiting

Busan,49241,South Korea

Novartis Investigative Site

Recruiting

Busan,48064,South Korea

Novartis Investigative Site

Recruiting

Busan,47524,South Korea

Novartis Investigative Site

Recruiting

Daejeon,Korea,35015,South Korea

Novartis Investigative Site

Recruiting

Iksan Si,Jeonlabuk Do,570-711,South Korea

Novartis Investigative Site

Recruiting

Suwon,Gyeonggi-do,16499,South Korea

Novartis Investigative Site

Recruiting

Guri-si,Gyeonggi-do,471-701,South Korea

Novartis Investigative Site

Recruiting

Goyang-si,Gyeonggi-do,10380,South Korea

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111