Alight (AMD light trial)
Research type
Research Study
Full title
Low-Level Night-Time Light Therapy for Age-Related Macular Degeneration
IRAS ID
117673
Contact name
Alison Binns
Contact email
Sponsor organisation
Cardiff University
Research summary
Age-related macular degeneration (AMD) is believed to affect more than 14 million people in Europe and North America and is the leading cause of visual impairment in the UK. Currently there are no treatments for early AMD and no treatments for the advanced form of the disease called geographic atrophy (GA), whilst the other advanced form of AMD (neovascular AMD, or nAMD) is treated at great expense by regular intraocular injections of the drug Lucentis. Advanced AMD is associated with vision loss, depression, social isolation, falls, and is a significant financial burden on the NHS.
The causes of AMD are not yet fully understood but hypoxia (insufficient oxygen) has been implicated. Hypoxia is most acute at night when the light sensitive film at the back of the eye, the retina, is most metabolically active. By exposing the eye to very dim light at night this hypoxia is reduced. In practice this involves wearing a light mask at night that emits a dim green light. This mask currently has CE marking for the treatment of a different retinal condition, diabetic retinopathy.
The primary aim of this trial is to determine if the light mask can stop the progression of early AMD. Sixty people with early AMD in one eye and nAMD in the fellow eye will be recruited from a Lucentis treatment clinic, half of whom will be randomly allocated to receive a sleep mask, and half to receive usual care only. In addition to evaluating disease progression, we also aim to assess the effect of the light mask on other outcome measures, including tests of visual function, the Lucentis retreatment rate in the eye with nAMD, and the ability to carry out daily tasks.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0609
Date of REC Opinion
29 Oct 2013
REC opinion
Further Information Favourable Opinion