Regulatory Post-Marketing Surveillance Study for Brolucizumab

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Geographic Atrophy

Treatment

brolucizumab

Clinical Study ID

NCT04985487
CRTH258AKR01
  • Ages 18-100
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as perapproved local product information

  2. Patients who consent to participate in the study after the purpose and nature of thestudy have clearly explained to them (written informed consent)

Exclusion

Exclusion Criteria:

  1. Contraindications as per local prescribing information 1) Hypersensitivity to theactive substance or to any of the excipients. 2) Active or suspected ocular orperiocular infection. 3) Active intraocular inflammation.

  2. Patients participating in other investigational drug trial

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: brolucizumab
Phase:
Study Start date:
August 18, 2021
Estimated Completion Date:
June 14, 2026

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Goyang si, Gyeonggi Do 10380
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

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

    Active - Recruiting

  • Novartis Investigative Site

    Suwon si, Gyeonggi Do 16499
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Guri-si, Gyeonggi-do 471-701
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Suwon-si, Gyeonggi-do 16499
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

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

    Active - Recruiting

  • Novartis Investigative Site

    Daejeon, Korea 35015
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Daegu, 705703
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Gwangju, 61489
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Incheon, 22332
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Jeju, 63206
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Pusan, 614 735
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, 04401
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Taegu, 41944
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.