Regulatory Post-Marketing Surveillance Study for Brolucizumab

NCT04985487 | Recruiting

• 1 other identifier: CRTH258AKR01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Neovascular Age-related Macular Degeneration

Keywords

nAMD; Neovascularized age related macular degeneration; Beovu; regulatory Post Marketing Study; Beovu Injection; Beovu Prefilled Syringe

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events at 12 weeks

  Incidence of adverse events and serious adverse events

  12 weeks

Secondary Outcomes (17)

• Incidence of adverse events at 24 weeks and optionally at 36 weeks

  Up to 36 weeks

• Proportion of patients gaining or losing more than 15 letters on the ETDRS chart

  Week 12, week 24, optionally week 36

• Mean change of Central Subfield Thickness (CST) from baseline

  Baseline, week 12, week 24, optionally week 36

• Mean change of Best Corrected Visual Acuity (BCVA) from baseline

  Baseline, week 12, week 24, optionally week 36

• Mean Best Corrected Visual Acuity (BCVA)

  Baseline, week 12, week 24, optionally week 36

Study Arms (1)

Brolucizumab

Patients prescribed with brolucizumab in the approved indication

Other: brolucizumab

Interventions

brolucizumab OTHER

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.

Also known as: Beovu

Brolucizumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥18 years who present to the participating study sites, where the decision to newly prescribe Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) were made prior to evaluating eligibility for this study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

Daegu, Dalseo Gu, 42602, South Korea

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

Daejeon, Korea, 35015, South Korea

RECRUITING

Novartis Investigative Site

Busan, 47524, South Korea

RECRUITING

Novartis Investigative Site

Busan, 48064, South Korea

RECRUITING

Novartis Investigative Site

Busan, 49241, South Korea

RECRUITING

Novartis Investigative Site

Daegu, 705 718, South Korea

RECRUITING

Novartis Investigative Site

Daegu, 705703, South Korea

RECRUITING

Novartis Investigative Site

Gwangju, 61489, South Korea

RECRUITING

Novartis Investigative Site

Gwangju, 61932, South Korea

RECRUITING

Novartis Investigative Site

Incheon, 22332, South Korea

RECRUITING

Novartis Investigative Site

Jeju City, 63206, South Korea

RECRUITING

Novartis Investigative Site

Pusan, 614 735, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 01000, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 02841, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03080, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 04401, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 04763, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 05368, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06273, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06351, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 07301, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 07441, South Korea

RECRUITING

Novartis Investigative Site

Taegu, 41944, South Korea

RECRUITING

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: August 18, 2021
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (28)