Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes <400 Microns

To join this study, you need to be an adult (over 18) and have either type 1 or type 2 diabetes. You must also have been diagnosed with severe diabetic macular oedema (DMO) where the centre of your macula was quite thick. Importantly, you should have started anti-VEGF eye injections for this severe DMO within the last year, and your macula swelling should now be less severe (meaning its thickness is below 400 microns) but you still have some fluid.

You would not be able to join if your macula swelling is still severe (400 microns or thicker), or if your eye problems are caused by something other than DMO. If you've received certain unlicensed anti-VEGF medicines, or if you can't attend all the study appointments, you also won't be suitable. If you have active 'proliferative diabetic retinopathy' (a different, more severe stage of diabetic eye disease) that hasn't been treated, or if you've recently had cataract surgery or specific laser treatments, you might also be excluded. Finally, if you're taking a diabetes medication called pioglitazone that you can't stop for the study duration, or are already in another specific type of clinical trial, you won't be able to participate.

If you decide to take part in this study, you will first have a number of tests and checks to make sure you are suitable. Once confirmed, you will be randomly assigned to one of two groups. One group will continue to receive only the anti-VEGF eye injections as needed. The other group will also start with anti-VEGF injections, but once the swelling in your macula reduces, they will switch to receiving the special Subthreshold Micropulse Laser (SML) treatment.

You will have regular appointments at the hospital eye clinic for eye examinations, vision tests, and scans of your macula. These assessments will help the study team monitor your eye health and the effectiveness of the treatment. The frequency of visits and specific treatments (injections or laser) will depend on which group you are in and how your eyes respond. This is an ongoing study, and your participation duration will depend on your individual response to treatment, but it is expected to involve regular follow-up over months or potentially years.