Regulatory Post-Marketing Surveillance Study for Brolucizumab

Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)

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

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Other: brolucizumab

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 47524
    • Recruiting
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 48064
    • Recruiting
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Novartis Investigative Site
  • Daegu, Korea, Republic of, 705703
    • Recruiting
    • Novartis Investigative Site
  • Daegu, Korea, Republic of, 705 718
    • Recruiting
    • Novartis Investigative Site
  • Gwangju, Korea, Republic of, 61489
    • Recruiting
    • Novartis Investigative Site
  • Gwangju, Korea, Republic of, 61932
    • Recruiting
    • Novartis Investigative Site
  • Incheon, Korea, Republic of, 22332
    • Recruiting
    • Novartis Investigative Site
  • Jeju, Korea, Republic of, 63206
    • Recruiting
    • Novartis Investigative Site
  • Pusan, Korea, Republic of, 614 735
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 04763
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07441
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06273
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 04401
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 07301
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 01000
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05368
    • Recruiting
    • Novartis Investigative Site
  • Taegu, Korea, Republic of, 41944
    • Recruiting
    • Novartis Investigative Site
  • Dalseo Gu
    • Daegu, Dalseo Gu, Korea, Republic of, 42602
      • Recruiting
      • Novartis Investigative Site
  • Gyeonggi Do
    • Goyang si, Gyeonggi Do, Korea, Republic of, 10380
      • Recruiting
      • Novartis Investigative Site
    • Guri Si, Gyeonggi Do, Korea, Republic of, 471-701
      • Recruiting
      • Novartis Investigative Site
    • Suwon si, Gyeonggi Do, Korea, Republic of, 16499
      • Recruiting
      • Novartis Investigative Site
  • Jeonlabuk Do
    • Iksan Si, Jeonlabuk Do, Korea, Republic of, 570-711
      • Recruiting
      • Novartis Investigative Site
  • Korea
    • Daejeon, Korea, Korea, Republic of, 35015
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brolucizumab; Patients prescribed with brolucizumab in the approved indication	Other: 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.; Other Names: Beovu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events at 12 weeks	Incidence of adverse events and serious adverse events	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events at 24 weeks and optionally at 36 weeks	Incidence of adverse events and serious adverse events	Up to 36 weeks
Proportion of patients gaining or losing more than 15 letters on the ETDRS chart	The ETDRS chart has been introduced as a standardized visual acuity (VA) testing chart. It uses 14 lines of 5 Sloan letter optotypes in each line in logarithmic progression. The space between lines and letters is proportionally equal keeping the effect of contour interaction constant. The threshold VA corresponds to the line in which 3 out of 5 optotypes were correctly identified. Alternatively, a by-letter scoring system (-0.02 logMAR credited for each letter correctly read) can be used. The testing distance can be varied; the corresponding visual acuity can be read easily from the chart. The chart is mounted on a box that is backlit by fluorescent tubes. For repeated measurements, the chart itself can be exchanged, providing different letters for different eyes.	Week 12, week 24, optionally week 36
Mean change of Central Subfield Thickness (CST) from baseline	CST is measured as one parameter by Optical coherence tomography.	Baseline, week 12, week 24, optionally week 36
Mean change of Best Corrected Visual Acuity (BCVA) from baseline	BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses	Baseline, week 12, week 24, optionally week 36
Mean Best Corrected Visual Acuity (BCVA)	BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses	Baseline, week 12, week 24, optionally week 36
Mean Central Subfield Thickness (CST)	CST is measured as one parameter by Optical coherence tomography.	Baseline, Week 12, week 24, optionally week 36
Number of injections	Number of Brolucizumab injections to be collected	Up to 36 weeks
Percentage of patients completing the loading phase	Loading phase: ≥ 3 injection during first 4 months	4 months
Percentage of patients who maintained with 12 weeks interval	Percentage(%) of patients who maintained with 12 weeks interval	Up to 36 weeks
Proportion of patients with retinal fluid	Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence	Week 12, week 24, optionally week 36
Prior anti-VEGF treatment history - number of prior injections	Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment	Baseline
Prior anti-VEGF treatment history - agent of prior injections	Agent of prior anti - vascular endothelial growth factor (VEGF) injections	Baseline
Predictive factors of treatment outcomes (persistent disease activity)	Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm	Week 24
Treatment naïve/non-naïve	Number of participants that are treatment naïve / non-naïve to be collected	Baseline
Treatment interval	Number of participants by treatment interval to be collected	Up to week 36
Concomitant treatments	Number of participants with concomitant treatments to be collected	Baseline
Number of participants with post injection empirical treatment	Post injection emperical treatment means any medication or therapy (usually topical medication such as topical antibiotics, topical steroid..etc.) routinely prescribed on the same day of injection in order to prevent post injection complications. It is differentiated from concomitant medication.	Week 12, week 24, optionally week 36

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: nAMD; Beovu; Neovascularized age related macular degeneration; regulatory Post Marketing Study; Beovu Injection; Beovu Prefilled Syringe
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: CRTH258AKR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO