Managing nAMD with a T&E aflibercept regimen
Research type
Research Study
Full title
Managing neovascular age-related macular degeneration (nAMD) over 2 years with a Treat and Extend (T&E) regimen of 2 mg intravitreal (IVT) aflibercept - a randomized, open-label, active-controlled, parallel-group phase IV/IIIb study (ARIES)
IRAS ID
179500
Contact name
Philip Hykin
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-003132-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 10 days
Research summary
Age-related macular degeneration (AMD) occurs when cells in the macula degenerate. Degeneration of the macula affects central vision which is needed for reading, writing, driving, recognising people's faces and doing other fine tasks. Age-related macular degeneration (AMD or ARMD) is the most common cause of vision loss in those aged over 50. It causes a gradual loss of central (but not peripheral) vision. AMD is the leading cause of visual impairment in the UK, affecting up to 500,000 people to some degree.
There is currently no cure for either type of AMD, but AMD can be treated with a type of medication called anti-VEGF medication (such as Eylea, which is already marketed in the UK), which aims to stop vision getting worse by helping prevent further blood vessels developing.
This study aims to see if earlier individualisation of treatment can reduce the burden on the patient and also reduce healthcare costs.
This study has two groups of participants, that will take part for 107 weeks (104 weeks of treatment). These will be allocated to groups randomly in a 1:1 ratio (like flipping a coin), after 3 months of treatment, to recieve the study drug Eylea under an early Treat and Extend (T&E) or late T&E regimen. Eylea will be administered via Intravitreal injection (injection to the eye) once per participant visit, by a suitably trained practitioner.
About 383 participants will be in the study across Europe.REC name
London - South East Research Ethics Committee
REC reference
16/LO/0055
Date of REC Opinion
17 Mar 2016
REC opinion
Further Information Favourable Opinion