Neovascular Age-related Macular Degeneration
Conditions
Keywords
brolucizumab intravitreal injections, nAMD, UK
Brief summary
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
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.
Interventions
OTHERbrolucizumab
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
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of nAMD 2. ≥50 years of age at index date 3. Receipt of at least one injection of brolucizumab during the eligibility period 4. Able and willing to provide signed informed consent
Exclusion criteria
1. 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 2. Receipt of anti-VEGF treatment other than brolucizumab in the index eye at index date 3. Any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date 4. Has been on anti-VEGF treatment for longer than 3 years (before index date) 5. 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) 6. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study 7. Participating in a parallel interventional clinical study 8. Participating in a parallel non-interventional study (NIS) generating primary data for an anti- VEGF drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of patients with absence of retinal fluid | Month 12 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of patients with ≥3 brolucizumab injections | Month 3 | Percentage of patients completing the loading phase to be collected |
| Percentage (%) of patients with absence of SRF | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Percentage (%) of patients without sub-retinal fluid (SRF) to be collected (fluid free) |
| Percentage (%) of patients with absence of IRF | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Percentage (%) of patients without intra-retinal fluid (IRF) to be collected (fluid-free) |
| Percentage (%) of patients with absence of sub-RPE fluid | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Percentage (%) of patients without sub-Retinal Pigment Epithelium fluid (sub-RPE) to be collected (fluid-free) |
| Percentage (%) of patients who switch from brolucizumab to another anti-VEGF | Month 12, month 24, month 36, month 48 and month 60 | Percentage of patients who switch from brolucizumab to another anti-VEGF to be collected |
| Percentage (%) of patients with absence of PED | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Percentage (%) of patients without retinal pigment epithelial detachment (PED) to be collected |
| Percentage (%) of patients with absence of retinal fluid | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | 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 |
| CRT change from baseline | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | measurement of Central Retinal Thickness (CRT) from baseline to be collected |
| Percentage (%) of patients that discontinue Brolucizumab therapy | Up to 60 months | Percentage of patients that discontinue therapy to be collected |
| BCVA change from baseline | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Change in Best Corrected Visual Acuity (BCVA) from baseline to be corrected |
| Percentage (%) of patients with BCVA ≥70 ETDRS letters | Month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Percentage of patients with Best Corrected Visual Acuity (BCVA) ≥70 ETDRS letters to be collected |
| Total number of injections received | Up to 60 months | 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 |
| Duration of injection intervals per patient | Up to 60 months | Duration of (all) injection intervals per patient during Months 0-6, 0-12, 13-24, 25-36, 37-48 and 49-60 |
| Percentage (%) of patients with IOI including RV and RVO | Up to 60 months | Percentage of patients with Intraocular Inflammation (IOI) including Retinal vasculitis (RV) and Retinal vascular occlusion (RVO) to be collected |
| Percentage (%) of patients with disease control | Month 12 and month 24 | 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 |
| Change in macular volume of IRF/SRF by central reading center | Baseline at Month 12 | 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. |
| CST change from baseline | Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60 | Measurement of Central Subfield Thickness (CST) from baseline to be collected |
Countries
United Kingdom
Outcome results
None listed