2RT Laser for Intermediate Age-Related Macular Degeneration
Research type
Research Study
Full title
A Pilot Study of 2RT Laser Application in Intermediate Age-Related Macular Degeneration (AMD)
IRAS ID
338881
Contact name
Paulo Eduardo Stanga
Contact email
Sponsor organisation
Nova Eye Medical
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Age-related Macular Degeneration (AMD) is a condition which affects over 1.5 million people in the UK alone over the age of 50. Most patients will have the "dry" form of AMD, characterised by progressive slow degeneration of the macula - the portion of the eye responsible for central sight. This degeneration is usually asymptomatic until either the cells have degenerated so much that they disappear altogether (known as macular atrophy), or, less commonly, the eye develops the "wet" form of AMD characterised by the leaking of blood and fluid at the macula, which causes much more rapid central sight loss.
Currently, the only UK-approved treatments for macular degeneration target patients with "wet" AMD (in the form of anti-VEGF eye injections). Globally, there are medications coming to approval to treat "dry" AMD, which predominantly work by suppressing certain proteins used in the immune system called "complement factors", however these are either in the form of eye injections, which must be repeated over a lifetime and carry small but considerable risk of sight loss from injection-related complications, or oral and systemic injectable treatments which carry the risk of side effects such as liver injury and infection.
2RT laser is a form of laser treatment for the eye designed to treat eyes with intermediate or moderate "dry" AMD, to prevent them from reaching the stage of sight loss or developing "wet" AMD. It is non-invasive so doesn't involve any eye injections, and carries no risk of drug side effects. Early in-human studies have shown that 2RT treatment is generally safe with a very low risk of sight-threatening complications, but more research is required to best optimise WHICH types of intermediate "dry" AMD will most benefit, WHICH treatment methods work best over time, and the side effects of these methods, which is the purpose of this study.
REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0192
Date of REC Opinion
19 Apr 2024
REC opinion
Further Information Favourable Opinion