Brolucizumab Treatment Experience Study of Patients With nAMD in UK Routine Clinical Practice

Study Overview
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Brief Summary
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BESRA is a national, multi-center, prospective, observational study to assess the effectiveness of brolucizumab intravitreal injections in patients with nAMD treated in the UK.

Detailed Description
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Data will be collected in a standardized manner from hospital medical records (paper and electronic) at participating centers for up to 60 months post- initiation of brolucizumab. In addition to the collection of data from medical records, retinal OCT images collected during the first two years of treatment will be transferred to a central reading center for independent grading and interpretation, in order to support the validity of anatomical measurements relevant to the primary and secondary study objectives. Patients will be treated with brolucizumab according to routine clinical practice, independent of the study setting. Key study design definitions: Index date: the date of the first brolucizumab injection. Index eye: the first eye to be injected with brolucizumab (analyses will be conducted for the index eye only, unless otherwise stated). Post-index period: time between index date and the earliest of treatment discontinuation, date of death or the date of the last recorded visit within the 60 months post-index (2-month window). Study period: The period between 01 September 2020 and 01 March 2027, to allow 6 months pre-index period and up to 60 months (±2 months window) follow-up for each enrolled patient.

Official Title
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Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)

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: Diagnosis of nAMD ≥50 years of age at index date Receipt of at least one injection of brolucizumab during the eligibility period Able and willing to provide signed informed consent Exclusion Criteria: Received treatment for retinal vein occlusion, diabetic macular edema (DME) and/or myopic choroidal neovascularization (mCNV), and/or has received a new diagnosis of diabetes-related macular degeneration in the index eye within 6 months prior to the index date Receipt of anti-VEGF treatment other than brolucizumab in the index eye at index date Any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date Has been on anti-VEGF treatment for longer than 3 years (before index date) Has a contraindication and is not eligible for treatment with brolucizumab according to the Beovu® (brolucizumab) Summary of Product Characteristics (SmPC) (Beovu 120 mg/ml solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) 2020) Any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study Participating in a parallel interventional clinical study Participating in a parallel non-interventional study (NIS) generating primary data for an anti- VEGF drug.

Ages Eligible for Study
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Minimum Age: 50 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>brolucizumab intravitreal injections in patients with nAMD treated in the UK | Other: brolucizumab<br>* There is no treatment allocation. The decision to administer brolucizumab is made by the treating physician independent of the study, prior to the inclusion of the patient into the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of patients with absence of retinal fluid | Percentage (%) of patients with absence of retinal fluid (no Sub-retinal Fluid (SRF) and no Intra-retinal fluid (IRF) as documented in medical records by the treating physician in relation to OCT results) | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of patients with absence of SRF | Percentage (%) of patients without sub-retinal fluid (SRF) to be collected (fluid free) | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients with absence of IRF | Percentage (%) of patients without intra-retinal fluid (IRF) to be collected (fluid-free) | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients with absence of sub-RPE fluid | Percentage (%) of patients without sub-Retinal Pigment Epithelium fluid (sub-RPE) to be collected (fluid-free) | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients with absence of PED | Percentage (%) of patients without retinal pigment epithelial detachment (PED) to be collected | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients with absence of retinal fluid | Percentage (%) of patients without intra-retinal fluid (IRF), Sub-retinal Fluid (SRF) and sub-Retinal pigment epithelium (sub-RPE) fluid (fluid free) to be collected | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| CRT change from baseline | measurement of Central Retinal Thickness (CRT) from baseline to be collected | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| CST change from baseline | Measurement of Central Subfield Thickness (CST) from baseline to be collected | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| BCVA change from baseline | Change in Best Corrected Visual Acuity (BCVA) from baseline to be corrected | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients with BCVA ≥70 ETDRS letters | Percentage of patients with Best Corrected Visual Acuity (BCVA) ≥70 ETDRS letters to be collected | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 
| Total number of injections received | Total number of injections received between Months 0 (index)-3, 4-6, 7-12, 0-12, 13-24, 25-36, 37-48, and 49-60 | Up to 60 months | 
| Duration of injection intervals per patient | Duration of (all) injection intervals per patient during Months 0-6, 0-12, 13-24, 25-36, 37-48 and 49-60 | Up to 60 months | 
| Percentage (%) of patients with ≥3 brolucizumab injections | Percentage of patients completing the loading phase to be collected | Month 3 | 
| Percentage (%) of patients who switch from brolucizumab to another anti-VEGF | Percentage of patients who switch from brolucizumab to another anti-VEGF to be collected | Month 12, month 24, month 36, month 48 and month 60 | 
| Percentage (%) of patients that discontinue Brolucizumab therapy | Percentage of patients that discontinue therapy to be collected | Up to 60 months | 
| Percentage (%) of patients with IOI including RV and RVO | Percentage of patients with Intraocular Inflammation (IOI) including Retinal vasculitis (RV) and Retinal vascular occlusion (RVO) to be collected | Up to 60 months | 
| Percentage (%) of patients with disease control | Percentage of patients with disease control, defined as absence of Intra-retinal fluid (IRF) and Sub-retinal Fluid (SRF), by the central reading center to be collected | Month 12 and month 24 | 
| Change in macular volume of IRF/SRF by central reading center | Change in macular volume of IRF/SRF by central reading center according to type of fluid available at baseline. Macular volume will be quantified using a specialized validated AI algorithm. | Baseline at Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brolucizumab intravitreal injections, nAMD, UK