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

Novartis

Status: Terminated

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Other: brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05112835

CRTH258AGB02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

302 participants in 1 patient group

brolucizumab

Description:

brolucizumab intravitreal injections in patients with nAMD treated in the UK

Treatment:

Other: brolucizumab