SAMADI
Research type
Research Study
Full title
Oral glycoside supplement (triterpenoid saponins) for early and intermediate stage age-related macular degeneration (AMD): an exploratory randomised placebo-controlled trial.
IRAS ID
1004543
Contact name
Tom Margrain
Contact email
Sponsor organisation
Cardiff University
Eudract number
2021-003045-38
Research summary
The trial aims to establish whether treatment of age-related macular degeneration (AMD) with oral glycoside supplements (ginseng & sea cucumber) is feasible and acceptable to patients.
AMD affects the central region of the light sensitive retina at the back of the eye (the macular). This region is responsible for seeing detail and colour, necessary for everyday activities like reading, driving, recognising faces. The condition develops gradually in the early stages but can progress rapidly in a minority of cases which develop a ‘wet’ form of the condition with severe vision loss if untreated. A contributing factor to the disease is a build-up of waste material around the membrane between the retina and the underlying layer of blood vessels. These blood vessels supply the retina with oxygen and nutrients as well as taking away waste. If waste builds up, it reduces the nutrients reaching the retina and can lead to vision loss.
The glycoside supplements have been shown to breakdown some of this waste material, a bit like soap, and allows it to be taken away by the blood in the blood vessels.
Sixty participants will be recruited in two sites, Cardiff & London, with early or intermediate AMD and randomised into two equal groups, one receiving oral glycoside tablets and the other placebo tablets, to be taken daily for 4 months. Baseline information will be obtained over two visits and a further two follow up visits will be carried out at 4 months and 12 months. We will use additional vision tests to produce images of the retina at the back of the eye, where changes due to AMD are visible.
A sub study will evaluate a new device called an ‘imaging retinal densitometer’ in Cardiff patients only. The device is extremely sensitive and assesses how the retina changes over time after it is exposed to light, a process known to be affected in early AMD.
REC name
HSC REC A
REC reference
24/NI/0019
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Favourable Opinion