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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05112835
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email [email protected]
Status Not yet recruiting
Phase
Start date November 11, 2021
Completion date September 1, 2027

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