Neovascular Age-related Macular DegenerationBESRANCT05112835
Brolucizumab Treatment Experience Study of Patients With nAMD in UK Routine Clinical Practice
An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- brolucizumab
- Type of treatment
- Injection or infusion
- How many people
- 302 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 19 Nov 2021to 8 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Novartis Investigative Site
Abergele, Conwy, LL22 8DP
Novartis Investigative Site
Barnsley, S75 2EP
Novartis Investigative Site
Bedford, MK429DJ
Novartis Investigative Site
Blackburn, Lancashire, BB2 3HH
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Coventry, CV2 2DX
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Glasgow, G11 6NT
Novartis Investigative Site
Hull, HU3 2JZ
Novartis Investigative Site
London, EC1V 2PD
Novartis Investigative Site
London, NW10 7NS
Novartis Investigative Site
Macclesfield, SK10 3BL
Novartis Investigative Site
Oxford, OX3 9DU
Novartis Investigative Site
Peterborough, Cambridgeshire, PE3 9GZ
Novartis Investigative Site
Sunderland, SR2 9HP
Novartis Investigative Site
Uxbridge, London, UB8 3NN
Novartis Investigative Site
Warwick, CV34 5BW
About this study
Official title: Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)
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.
Read the 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.
- Being tested
- brolucizumab
- Keywords
- brolucizumab intravitreal injections, nAMD, UK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabOther
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
| Study group | Role | What they receive |
|---|---|---|
| brolucizumab | brolucizumab intravitreal injections in patients with nAMD treated in the UK Receives: Other: brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 12
Secondary outcomes (17)
Percentage (%) of patients with absence of SRF
Percentage (%) of patients without sub-retinal fluid (SRF) to be collected (fluid free)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 60 months
Percentage (%) of patients with ≥3 brolucizumab injections
Percentage of patients completing the loading phase to be collected
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start19 Nov 2021
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112835
- Sponsor's protocol ID
- CRTH258AGB02
- Acronym
- BESRA
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)
- ClinicalTrials.gov ID
- NCT05112835
- Acronym / sponsor ID
- BESRA / CRTH258AGB02
- Keywords
- brolucizumab intravitreal injections, nAMD, UK
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brolucizumab | – | Other: brolucizumabbrolucizumab intravitreal injections in patients with nAMD treated in the UK |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brolucizumabThere 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 | Other | brolucizumab |
Primary outcome
Percentage (%) of patients with absence of retinal fluid
Time frame: 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)
17 secondary outcomes
Percentage (%) of patients with absence of SRF
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with absence of IRF
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with absence of sub-RPE fluid
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with absence of PED
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with absence of retinal fluid
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
CRT change from baseline
Time frame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
CST change from baseline
Time frame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
BCVA change from baseline
Time frame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients with BCVA ≥70 ETDRS letters
Time frame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Total number of injections received
Time frame: Up to 60 months
Duration of injection intervals per patient
Time frame: Up to 60 months
Percentage (%) of patients with ≥3 brolucizumab injections
Time frame: Month 3
Percentage (%) of patients who switch from brolucizumab to another anti-VEGF
Time frame: Month 12, month 24, month 36, month 48 and month 60
Percentage (%) of patients that discontinue Brolucizumab therapy
Time frame: Up to 60 months
Percentage (%) of patients with IOI including RV and RVO
Time frame: Up to 60 months
Percentage (%) of patients with disease control
Time frame: Month 12 and month 24
Change in macular volume of IRF/SRF by central reading center
Time frame: Baseline at Month 12
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results for CRTH258AGB02 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of patients with absence of retinal fluid (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.