Clinical trial NCT04985487: Regulatory Post-Marketing Surveillance Study for Brolucizumab
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular Age-related Macular Degeneration
Keywords: nAMD
Neovascularized age related macular degeneration
Beovu
regulatory Post Marketing Study
Beovu Injection
Beovu Prefilled Syringe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: Incidence of adverse events at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events at 24 weeks and optionally at 36 weeks
timeFrame: Up to 36 weeks
measure: Proportion of patients gaining or losing more than 15 letters on the ETDRS chart
timeFrame: Week 12, week 24, optionally week 36
measure: Mean change of Central Subfield Thickness (CST) from baseline
timeFrame: Baseline, week 12, week 24, optionally week 36
measure: Mean change of Best Corrected Visual Acuity (BCVA) from baseline
timeFrame: Baseline, week 12, week 24, optionally week 36
measure: Mean Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, week 12, week 24, optionally week 36
measure: Mean Central Subfield Thickness (CST)
timeFrame: Baseline, Week 12, week 24, optionally week 36
measure: Number of injections
timeFrame: Up to 36 weeks
measure: Percentage of patients completing the loading phase
timeFrame: 4 months
measure: Percentage of patients who maintained with 12 weeks interval
timeFrame: Up to 36 weeks
measure: Proportion of patients with retinal fluid
timeFrame: Week 12, week 24, optionally week 36
measure: Prior anti-VEGF treatment history - number of prior injections
timeFrame: Baseline
measure: Prior anti-VEGF treatment history - agent of prior injections
timeFrame: Baseline
measure: Predictive factors of treatment outcomes (persistent disease activity)
timeFrame: Week 24
measure: Treatment naïve/non-naïve
timeFrame: Baseline
measure: Treatment interval
timeFrame: Up to week 36
measure: Concomitant treatments
timeFrame: Baseline
measure: Number of participants with post injection empirical treatment
timeFrame: Week 12, week 24, optionally week 36
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Dalseo Gu
city: Goyang si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Guri Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Suwon si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Iksan Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeonlabuk Do
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Gwangju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taegu
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: