TARVOS - Non-interventional Study
Research type
Research Study
Full title
TARVOS – Treat & extend Intravitreal Aflibercept: Resource use, service implementation, quality of life, developing standards
IRAS ID
279371
Contact name
Martin McKibbin
Contact email
Sponsor organisation
Bayer Plc
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Age-related macular degeneration (AMD) is the leading cause of blindness in people over the age of 50 in developed countries and is characterised by central vision loss.
Wet AMD (wAMD), the most serious and severe form of AMD occurs when blood vessels grow abnormally beneath the macula and damage the retina. This process is called angiogenesis and is driven by the presence of Vascular Endothelial Growth Factor (VEGF).
These abnormal vessels leak fluid and blood eventually leading to irreversible vision loss if left untreated.
Administration of anti-VEGF treatment for wAMD has evolved from a fixed monthly dosing regimen, to a reactive pro re nata (PRN) approach, and more recently a proactive bimonthly dosing and/or ‘Treat and Extend’ (T&E) posology following initial monthly dosing.
Recent observational studies have demonstrated favourable results when a T&E posology is applied in routine clinical practice. In addition, adoption of an optimal T&E regimen could reduce the treatment burden on patients, and may also alleviate capacity constraints within the clinic.
This non-interventional cohort field study seeks to examine the implementation of an IVT aflibercept based T&E service within the UK, focusing primarily on the patient’s QoL and treatment burden.
Practicalities associated with an IVT aflibercept T&E posology for wAMD in the UK National Health Service (NHS) setting will also be assessed.
This information will help to develop patient centred recommendations for an optimised implementation of IVT aflibercept T&E service which can be applied across the NHS.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0099
Date of REC Opinion
8 Apr 2020
REC opinion
Favourable Opinion