Actively Recruiting

Age: 18Years - 100Years
All Genders
ID04985487

Post-Marketing Safety and Effectiveness Study of Brolucizumab Injection for Neovascular Age-related Macular Degeneration

Led by Novartis Pharmaceuticals · Updated on 2025-01-14

3000

Participants Needed

28

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an open-label, multicenter, single-arm observational study to monitor patients with neovascular age-related macular degeneration (nAMD) who are prescribed brolucizumab (Beovu® Injection, Beovu® Prefilled Syringe). The study aims to gather safety information and evaluate the effectiveness of brolucizumab in real-world use following its approved indication. This post-marketing surveillance study collects data over a 12-week period, with additional longer-term data collection planned at 24 and optionally 36 weeks. Participants in this study have already started treatment with brolucizumab before being enrolled, as there is no treatment allocation or randomization. The study is purely observational, focusing on those prescribed brolucizumab according to the approved local product information. No changes to their treatment are made as part of the study. During the study, researchers will monitor participants for adverse events and treatment outcomes, with the primary outcome being the incidence of adverse events observed within the first 12 weeks. Participants will be followed for safety and effectiveness assessments throughout the study duration, including optional longer-term follow-ups up to 36 weeks.

CONDITIONS

Official Title

Regulatory Post-Marketing Surveillance Study for Brolucizumab

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years with neovascular age-related macular degeneration prescribed brolucizumab according to approved local product information
  • Patients who provide written informed consent after understanding the study purpose and nature
Not Eligible

You will not qualify if you...

  • Hypersensitivity to brolucizumab or any excipients
  • Active or suspected ocular or periocular infection
  • Active intraocular inflammation
  • Participation in other investigational drug trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea, 42602

Actively Recruiting

2

Novartis Investigative Site

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

Actively Recruiting

3

Novartis Investigative Site

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

Actively Recruiting

4

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea, 16499

Actively Recruiting

5

Novartis Investigative Site

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

Actively Recruiting

6

Novartis Investigative Site

Daejeon, Korea, South Korea, 35015

Actively Recruiting

7

Novartis Investigative Site

Busan, South Korea, 47524

Actively Recruiting

8

Novartis Investigative Site

Busan, South Korea, 48064

Actively Recruiting

9

Novartis Investigative Site

Busan, South Korea, 49241

Actively Recruiting

10

Novartis Investigative Site

Daegu, South Korea, 705 718

Actively Recruiting

11

Novartis Investigative Site

Daegu, South Korea, 705703

Actively Recruiting

12

Novartis Investigative Site

Gwangju, South Korea, 61489

Actively Recruiting

13

Novartis Investigative Site

Gwangju, South Korea, 61932

Actively Recruiting

14

Novartis Investigative Site

Incheon, South Korea, 22332

Actively Recruiting

15

Novartis Investigative Site

Jeju City, South Korea, 63206

Actively Recruiting

16

Novartis Investigative Site

Pusan, South Korea, 614 735

Actively Recruiting

17

Novartis Investigative Site

Seoul, South Korea, 01000

Actively Recruiting

18

Novartis Investigative Site

Seoul, South Korea, 02841

Actively Recruiting

19

Novartis Investigative Site

Seoul, South Korea, 03080

Actively Recruiting

20

Novartis Investigative Site

Seoul, South Korea, 03722

Actively Recruiting

21

Novartis Investigative Site

Seoul, South Korea, 04401

Actively Recruiting

22

Novartis Investigative Site

Seoul, South Korea, 04763

Actively Recruiting

23

Novartis Investigative Site

Seoul, South Korea, 05368

Actively Recruiting

24

Novartis Investigative Site

Seoul, South Korea, 06273

Actively Recruiting

25

Novartis Investigative Site

Seoul, South Korea, 06351

Actively Recruiting

26

Novartis Investigative Site

Seoul, South Korea, 07301

Actively Recruiting

27

Novartis Investigative Site

Seoul, South Korea, 07441

Actively Recruiting

28

Novartis Investigative Site

Taegu, South Korea, 41944

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

N

Novartis Pharmaceuticals

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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