Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 28 locations
1
Novartis Investigative Site
Daegu, Dalseo Gu, South Korea, 42602
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2
Novartis Investigative Site
Goyang-si, Gyeonggi-do, South Korea, 10380
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3
Novartis Investigative Site
Guri-si, Gyeonggi-do, South Korea, 471-701
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4
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea, 16499
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5
Novartis Investigative Site
Iksan Si, Jeonlabuk Do, South Korea, 570-711
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6
Novartis Investigative Site
Daejeon, Korea, South Korea, 35015
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7
Novartis Investigative Site
Busan, South Korea, 47524
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8
Novartis Investigative Site
Busan, South Korea, 48064
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9
Novartis Investigative Site
Busan, South Korea, 49241
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10
Novartis Investigative Site
Daegu, South Korea, 705 718
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11
Novartis Investigative Site
Daegu, South Korea, 705703
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12
Novartis Investigative Site
Gwangju, South Korea, 61489
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13
Novartis Investigative Site
Gwangju, South Korea, 61932
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14
Novartis Investigative Site
Incheon, South Korea, 22332
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15
Novartis Investigative Site
Jeju City, South Korea, 63206
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16
Novartis Investigative Site
Pusan, South Korea, 614 735
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17
Novartis Investigative Site
Seoul, South Korea, 01000
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18
Novartis Investigative Site
Seoul, South Korea, 02841
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19
Novartis Investigative Site
Seoul, South Korea, 03080
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20
Novartis Investigative Site
Seoul, South Korea, 03722
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21
Novartis Investigative Site
Seoul, South Korea, 04401
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22
Novartis Investigative Site
Seoul, South Korea, 04763
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23
Novartis Investigative Site
Seoul, South Korea, 05368
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24
Novartis Investigative Site
Seoul, South Korea, 06273
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25
Novartis Investigative Site
Seoul, South Korea, 06351
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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
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
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