NCT05112835

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

Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2021-11-09
• Last updated: 2024-10-29

Locations

17 sites across 1 country: United Kingdom