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)

ClinicalTrials.gov Identifier: NCT05112835

Novartis Reference Number: CRTH258AGB02

Last Update: Jan 19, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Neovascular Age-related Macular Degeneration
Phase 
Not Given
Overall status 
Recruiting
Start date 
Nov 19, 2021
Completion date 
Sep 01, 2027
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

Diagnosis of nAMD
≥50 years of age at index date
Receipt of at least one injection of brolucizumab during the eligibility period
Able and willing to provide signed informed consent

Exclusion Criteria:

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
Receipt of anti-VEGF treatment other than brolucizumab in the index eye at index date
Any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date
Has been on anti-VEGF treatment for longer than 3 years (before index date)
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)
Any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study
Participating in a parallel interventional clinical study
Participating in a parallel non-interventional study (NIS) generating primary data for an anti- VEGF drug.

Study Locations

United Kingdom
Novartis Investigative Site
Recruiting
Peterborough, PE3 9GZ
Cambridgeshire
United Kingdom
Novartis Investigative Site
Recruiting
Abergele, LL22 8DP
Conwy
United Kingdom
Novartis Investigative Site
Recruiting
Blackburn, BB2 3HH
Lancashire
United Kingdom
Novartis Investigative Site
Recruiting
Uxbridge, UB8 3NN
London
United Kingdom
Novartis Investigative Site
Recruiting
Frimley, GU16 7UJ
Surrey
United Kingdom
Novartis Investigative Site
Recruiting
Bradford, BD9 6RJ
West Yorkshire
United Kingdom
Novartis Investigative Site
Recruiting
Barnsley, S75 2EP
-
United Kingdom
Novartis Investigative Site
Recruiting
Coventry, CV2 2DX
-
United Kingdom
Novartis Investigative Site
Recruiting
Hull, HU3 2JZ
-
United Kingdom
Novartis Investigative Site
Recruiting
London, EC1V 2PD
-
United Kingdom
Novartis Investigative Site
Recruiting
Warwick, CV34 5BW
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]