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

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.

Study Overview

• Status: Terminated
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Other: brolucizumab

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 Type: Observational
• Enrollment (Actual): 302

Contacts and Locations

Study Locations

• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Novartis Investigative Site
  • Bedford, United Kingdom, MK429DJ
    • Novartis Investigative Site
  • Coventry, United Kingdom, CV2 2DX
    • Novartis Investigative Site
  • Glasgow, United Kingdom, G11 6NT
    • Novartis Investigative Site
  • Hull, United Kingdom, HU3 2JZ
    • Novartis Investigative Site
  • London, United Kingdom, EC1V 2PD
    • Novartis Investigative Site
  • London, United Kingdom, NW10 7NS
    • Novartis Investigative Site
  • Macclesfield, United Kingdom, SK10 3BL
    • Novartis Investigative Site
  • Oxford, United Kingdom, OX3 9DU
    • Novartis Investigative Site
  • Sunderland, United Kingdom, SR2 9HP
    • Novartis Investigative Site
  • Warwick, United Kingdom, CV34 5BW
    • Novartis Investigative Site
  • Cambridgeshire
    • Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
      • Novartis Investigative Site
  • Conwy
    • Abergele, Conwy, United Kingdom, LL22 8DP
      • Novartis Investigative Site
  • Lancashire
    • Blackburn, Lancashire, United Kingdom, BB2 3HH
      • Novartis Investigative Site
  • London
    • Uxbridge, London, United Kingdom, UB8 3NN
      • Novartis Investigative Site
  • Surrey
    • Frimley, Surrey, United Kingdom, GU16 7UJ
      • Novartis Investigative Site
  • West Yorkshire
    • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
brolucizumab; brolucizumab intravitreal injections in patients with nAMD treated in the UK	Other: brolucizumab; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRTH258AGB02 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: nAMD; UK; brolucizumab intravitreal injections
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CRTH258AGB02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO