Regulatory Post-Marketing Surveillance Study for Brolucizumab

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

Detailed Description
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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.

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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Other: brolucizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brolucizumab<br>Patients prescribed with brolucizumab in the approved indication | Other: brolucizumab<br>* 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.<br>* Other names: Beovu;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nAMD, Neovascularized age related macular degeneration, Beovu, regulatory Post Marketing Study, Beovu Injection, Beovu Prefilled Syringe