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Clinical Trials in South Korea / NCT04985487
Recruiting Observational

Regulatory Post-Marketing Surveillance Study for Brolucizumab

NCT04985487 · tracked via the Priya Life Science South Korea tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2021-08-18
Last updated
2025-01-14

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

brolucizumab

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of adverse events at 12 weeks — 12 weeks
    Incidence of adverse events and serious adverse events

Trial sites (28)

FacilityCityRegionStatus
Novartis Investigative Site Daegu Dalseo Gu Recruiting
Novartis Investigative Site Goyang-si Gyeonggi-do Recruiting
Novartis Investigative Site Guri-si Gyeonggi-do Recruiting
Novartis Investigative Site Suwon Gyeonggi-do Recruiting
Novartis Investigative Site Iksan Si Jeonlabuk Do Recruiting
Novartis Investigative Site Daejeon Korea Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Busan South Korea Recruiting
Novartis Investigative Site Daegu South Korea Recruiting
Novartis Investigative Site Daegu South Korea Recruiting
Novartis Investigative Site Gwangju South Korea Recruiting
Novartis Investigative Site Gwangju South Korea Recruiting
Novartis Investigative Site Incheon South Korea Recruiting
Novartis Investigative Site Jeju City South Korea Recruiting
Novartis Investigative Site Pusan South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Seoul South Korea Recruiting
Novartis Investigative Site Taegu South Korea Recruiting

More Novartis Pharmaceuticals trials in South Korea

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Active, not recruiting
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea) Recruiting
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy Recruiting
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Active, not recruiting
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes Recruiting

Other trials for the same condition

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD Recruiting
A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products Active, not recruiting
A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04985487 on ClinicalTrials.gov ↗ ← All trials in South Korea