RecruitingNCT04985487

Regulatory Post-Marketing Surveillance Study for Brolucizumab

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


Sponsor

Novartis Pharmaceuticals

Enrollment

3,000 participants

Start Date

Aug 18, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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

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Interventions

OTHERbrolucizumab

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.


Locations(28)

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea

Novartis Investigative Site

Goyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Guri-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Novartis Investigative Site

Iksan Si, Jeonlabuk Do, South Korea

Novartis Investigative Site

Daejeon, Korea, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Daegu, South Korea

Novartis Investigative Site

Daegu, South Korea

Novartis Investigative Site

Gwangju, South Korea

Novartis Investigative Site

Gwangju, South Korea

Novartis Investigative Site

Incheon, South Korea

Novartis Investigative Site

Jeju City, South Korea

Novartis Investigative Site

Pusan, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Taegu, South Korea

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NCT04985487


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