Regulatory Post-Marketing Surveillance Study for Brolucizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: brolucizumab.
- Who it may be relevant to
- Registry conditions: Neovascular Age-related Macular Degeneration. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
Overview
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.
Interventions
- 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.
Primary outcome measures
- Incidence of adverse events at 12 weeks [Time frame: 12 weeks]
Secondary outcome measures (12)
- Incidence of adverse events at 24 weeks and optionally at 36 weeks [Time frame: Up to 36 weeks]
- Proportion of patients gaining or losing more than 15 letters on the ETDRS chart [Time frame: Week 12, week 24, optionally week 36]
- Mean change of Central Subfield Thickness (CST) from baseline [Time frame: Baseline, week 12, week 24, optionally week 36]
- Mean change of Best Corrected Visual Acuity (BCVA) from baseline [Time frame: Baseline, week 12, week 24, optionally week 36]
- Mean Best Corrected Visual Acuity (BCVA) [Time frame: Baseline, week 12, week 24, optionally week 36]
- Mean Central Subfield Thickness (CST) [Time frame: Baseline, Week 12, week 24, optionally week 36]
- Number of injections [Time frame: Up to 36 weeks]
- Percentage of patients completing the loading phase [Time frame: 4 months]
- Percentage of patients who maintained with 12 weeks interval [Time frame: Up to 36 weeks]
- Proportion of patients with retinal fluid [Time frame: Week 12, week 24, optionally week 36]
- Prior anti-VEGF treatment history - number of prior injections [Time frame: Baseline]
- Prior anti-VEGF treatment history - agent of prior injections [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 28 centers
- Novartis Investigative Site — Daegu
- Novartis Investigative Site — Goyang-si
- Novartis Investigative Site — Guri-si
- Novartis Investigative Site — Suwon
- Novartis Investigative Site — Iksan Si
- Novartis Investigative Site — Daejeon
- Novartis Investigative Site — Busan
- Novartis Investigative Site — Busan
- … and 20 more centers
Identifiers
NCT: NCT04985487 · CRTH258AKR01