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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Noemi
Lois
n.lois@qub.ac.uk
Mrs
Mary
Guiney
dame@nictu.hscni.net
More information about this study, what is involved and how to take part can be found on the study website.
Severe diabetic macular oedema (DMO).
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (µm), how thick the macula is. One µm is one-thousandth of a millimetre.
People presenting with mild DMO (macula less than 400 µm thick; normally it is around 250 µm but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective.
However, many people present with severe DMO (macula 400 µm or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again.
To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 µm thick.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Causes of macular oedema other than DMO2. DMO with CRT ≥400 μm3. Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed)4. Use of unlicensed anti-VEGFs (e.g. bevacizumab)5. Inability, for any reason, to attend study visits6. Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed)7. Use of pioglitazone which cannot be stopped for the duration of the trial8. Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks9. Currently enrolled in a CTIMP (Clinical Trial of an Investigational Medical Product)10. Declined consent for participation
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Noemi
Lois
n.lois@qub.ac.uk
Mrs
Mary
Guiney
dame@nictu.hscni.net
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Belfast Health and Social Care Trust and funded by National Institute for Health and Care Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS: 65230
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
