Regulatory Post-Marketing Surveillance Study for Brolucizumab

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Other: brolucizumab

• Registration Number: NCT04985487
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-02
• Study Start: 2021-08-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-08
• Primary Completion: 2026-06-14
• Study Completion: 2026-06-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brolucizumab	brolucizumab	Patients prescribed with brolucizumab in the approved indication

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events at 12 weeks	12 weeks	Incidence of adverse events and serious adverse events

Secondary Outcome Measures

Name	Time	Method
Mean change of Central Subfield Thickness (CST) from baseline	Baseline, week 12, week 24, optionally week 36	CST is measured as one parameter by Optical coherence tomography.
Mean Central Subfield Thickness (CST)	Baseline, Week 12, week 24, optionally week 36	CST is measured as one parameter by Optical coherence tomography.
Proportion of patients gaining or losing more than 15 letters on the ETDRS chart	Week 12, week 24, optionally week 36	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.
Predictive factors of treatment outcomes (persistent disease activity)	Week 24	Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm
Number of participants with post injection empirical treatment	Week 12, week 24, optionally week 36	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.
Percentage of patients completing the loading phase	4 months	Loading phase: ≥ 3 injection during first 4 months
Mean Best Corrected Visual Acuity (BCVA)	Baseline, week 12, week 24, optionally week 36	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
Incidence of adverse events at 24 weeks and optionally at 36 weeks	Up to 36 weeks	Incidence of adverse events and serious adverse events
Mean change of Best Corrected Visual Acuity (BCVA) from baseline	Baseline, week 12, week 24, optionally week 36	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
Number of injections	Up to 36 weeks	Number of Brolucizumab injections to be collected
Percentage of patients who maintained with 12 weeks interval	Up to 36 weeks	Percentage(%) of patients who maintained with 12 weeks interval
Proportion of patients with retinal fluid	Week 12, week 24, optionally week 36	Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence
Prior anti-VEGF treatment history - number of prior injections	Baseline	Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment
Prior anti-VEGF treatment history - agent of prior injections	Baseline	Agent of prior anti - vascular endothelial growth factor (VEGF) injections
Treatment naïve/non-naïve	Baseline	Number of participants that are treatment naïve / non-naïve to be collected
Treatment interval	Up to week 36	Number of participants by treatment interval to be collected
Concomitant treatments	Baseline	Number of participants with concomitant treatments to be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Taegu, Korea, Republic of