Study Stopped
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Brolucizumab Treatment Experience Study of Patients With nAMD in UK Routine Clinical Practice
BESRA
1 other identifier
observational
302
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedStudy Start
First participant enrolled
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2022
CompletedOctober 29, 2024
October 1, 2024
10 months
October 28, 2021
October 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
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 with absence of IRF
Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
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 with absence of PED
Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with absence of retinal fluid
Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
- +12 more secondary outcomes
Study Arms (1)
brolucizumab
brolucizumab intravitreal injections in patients with nAMD treated in the UK
Interventions
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
Eligibility Criteria
This study will involve the collection of data on adult patients with nAMD who have been newly initiated on brolucizumab at a participating NHS hospital
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom
Novartis Investigative Site
Abergele, Conwy, LL22 8DP, United Kingdom
Novartis Investigative Site
Blackburn, Lancashire, BB2 3HH, United Kingdom
Novartis Investigative Site
Uxbridge, London, UB8 3NN, United Kingdom
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ, United Kingdom
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Novartis Investigative Site
Barnsley, S75 2EP, United Kingdom
Novartis Investigative Site
Bedford, MK429DJ, United Kingdom
Novartis Investigative Site
Coventry, CV2 2DX, United Kingdom
Novartis Investigative Site
Glasgow, G11 6NT, United Kingdom
Novartis Investigative Site
Hull, HU3 2JZ, United Kingdom
Novartis Investigative Site
London, EC1V 2PD, United Kingdom
Novartis Investigative Site
London, NW10 7NS, United Kingdom
Novartis Investigative Site
Macclesfield, SK10 3BL, United Kingdom
Novartis Investigative Site
Oxford, OX3 9DU, United Kingdom
Novartis Investigative Site
Sunderland, SR2 9HP, United Kingdom
Novartis Investigative Site
Warwick, CV34 5BW, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 9, 2021
Study Start
November 19, 2021
Primary Completion
September 8, 2022
Study Completion
September 8, 2022
Last Updated
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share