Brolucizumab Treatment in Patients with nAMD in the UK
Research type
Research Study
Full title
Brolucizumab Treatment Experience Study of Patients with Neovascular Age-related Macular Degeneration (nAMD) in UK routine clinical practice (BESRA)
IRAS ID
303653
Contact name
Faruque Ghanchi
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
5 years, 10 months, 31 days
Research summary
Summary of Research
Neovascular age-related macular degeneration (nAMD) is a rapidly-progressing eye condition that can result in loss of central vision. Brolucizumab is an approved treatment for nAMD. The purpose of this study is to understand what happens to patients with nAMD who are treated with brolucizumab as part of their routine care in the United Kingdom (UK) and how well the treatment works for them in the 5-year period after starting the treatment.
This is a national, multi-centre, prospective, observational study. This study will be conducted in up to 30 health centres in the UK. The study is based on prospective collection of data from patients’ medical records for up to 5 years after the initiation of brolucizumab, with additional independent review and interpretation of pseudo-anonymised retinal imaging results collected during the first two years of treatment.
There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.
The population for this study is adult patients diagnosed with nAMD who have been initiated on brolucizumab as part of their standard clinical care. It is expected to recruit 600 patients in total.Summary of Results
N/A - lay summary is not mandatory for a non-interventional study, no lay summary has been produced for this studyREC name
HSC REC B
REC reference
21/NI/0145
Date of REC Opinion
24 Aug 2021
REC opinion
Favourable Opinion