Last Update: Oct 08, 2024
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CRTH258AKR01
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 - (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

Seoul,07441,Korea, Republic of

Novartis Investigative Site

Recruiting

Busan,48064,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,04401,Korea, Republic of

Novartis Investigative Site

Recruiting

Goyang si,Gyeonggi Do,10380,Korea, Republic of

Novartis Investigative Site

Recruiting

Jeju,63206,Korea, Republic of

Novartis Investigative Site

Recruiting

Taegu,41944,Korea, Republic of

Novartis Investigative Site

Recruiting

Busan,49241,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,04763,Korea, Republic of

Novartis Investigative Site

Recruiting

Guri Si,Gyeonggi Do,471-701,Korea, Republic of

Novartis Investigative Site

Recruiting

Pusan,614 735,Korea, Republic of

Novartis Investigative Site

Recruiting

Daegu,705 718,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,05368,Korea, Republic of

Novartis Investigative Site

Recruiting

Suwon si,Gyeonggi Do,16499,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,01000,Korea, Republic of

Novartis Investigative Site

Recruiting

Daegu,705703,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,06273,Korea, Republic of

Novartis Investigative Site

Recruiting

Iksan Si,Jeonlabuk Do,570-711,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,02841,Korea, Republic of

Novartis Investigative Site

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Gwangju,61489,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,06351,Korea, Republic of

Novartis Investigative Site

Recruiting

Daejeon,Korea,35015,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,03080,Korea, Republic of

Novartis Investigative Site

Recruiting

Gwangju,61932,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,07301,Korea, Republic of

Novartis Investigative Site

Recruiting

Busan,47524,Korea, Republic of

Novartis Investigative Site

Recruiting

Seoul,03722,Korea, Republic of

Novartis Investigative Site

Recruiting

Daegu,Dalseo Gu,42602,Korea, Republic of

Novartis Investigative Site

Recruiting

Incheon,22332,Korea, Republic of

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