Clinical trial NCT05112835: Brolucizumab Treatment Experience Study of Patients With nAMD in UK Routine Clinical Practice
Official title: Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: brolucizumab intravitreal injections
nAMD
UK
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 302
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage (%) of patients with absence of retinal fluid
timeFrame: Month 12
Secondary outcomes:
measure: Percentage (%) of patients with absence of SRF
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients with absence of IRF
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients with absence of sub-RPE fluid
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients with absence of PED
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients with absence of retinal fluid
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: CRT change from baseline
timeFrame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: CST change from baseline
timeFrame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: BCVA change from baseline
timeFrame: Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients with BCVA ≥70 ETDRS letters
timeFrame: Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
measure: Total number of injections received
timeFrame: Up to 60 months
measure: Duration of injection intervals per patient
timeFrame: Up to 60 months
measure: Percentage (%) of patients with ≥3 brolucizumab injections
timeFrame: Month 3
measure: Percentage (%) of patients who switch from brolucizumab to another anti-VEGF
timeFrame: Month 12, month 24, month 36, month 48 and month 60
measure: Percentage (%) of patients that discontinue Brolucizumab therapy
timeFrame: Up to 60 months
measure: Percentage (%) of patients with IOI including RV and RVO
timeFrame: Up to 60 months
measure: Percentage (%) of patients with disease control
timeFrame: Month 12 and month 24
measure: Change in macular volume of IRF/SRF by central reading center
timeFrame: Baseline at Month 12
Other outcomes:
Locations:
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
state: Cambridgeshire
city: Abergele
country: United Kingdom
facility: Novartis Investigative Site
state: Conwy
city: Blackburn
country: United Kingdom
facility: Novartis Investigative Site
state: Lancashire
city: Uxbridge
country: United Kingdom
facility: Novartis Investigative Site
state: London
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Barnsley
country: United Kingdom
facility: Novartis Investigative Site
city: Bedford
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Macclesfield
country: United Kingdom
facility: Novartis Investigative Site
city: Oxford
country: United Kingdom
facility: Novartis Investigative Site
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
city: Warwick
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: