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

Description

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. Patients aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 µm thick.

Interventions

• Subthreshold Micropulse Laser (SML) (Procedure)
  SML will be applied in line with the DAME Guideline and follow the DAME participant pathway.
• Anti-VEGF Monotherapy (standard care) (Drug)
  Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites. The anti-VEGF should be administered in line with the summary of product characteristics (SmPC).

Eligibility criteria

Conditions

Locations

• Bedford Hospital — Bedford, United Kingdom
• The Royal Hospitals Belfast — Belfast, United Kingdom
• Birmingham and Midland Eye Centre — Birmingham, United Kingdom
• Sussex Eye Hospital — Brighton, United Kingdom
• Bristol Eye Hospital — Bristol, United Kingdom
• Frimley Park Hospital — Camberley, United Kingdom
• University Hospital of Wales — Cardiff, United Kingdom
• Gloucestershire Royal Hospital — Gloucester, United Kingdom
• Hull Royal Infirmary — Hull, United Kingdom
• Royal Liverpool University Hospital — Liverpool, United Kingdom
• Central Middlesex Hospital — London, United Kingdom
• Chelsea and Westminster Hospital — London, United Kingdom
• Kings College Hospital — London, United Kingdom
• Moorfields Eye Hospital — London, United Kingdom
• James Cook Hospital — Middlesbrough, United Kingdom
• Royal Gwent Hospital — Newport, United Kingdom
• Queen's Medical Centre — Nottingham, United Kingdom
• University Hospital Southampton — Southampton, United Kingdom
• Sunderland Eye Hospital — Sunderland, United Kingdom
• Singleton Hospital — Swansea, United Kingdom
• Torbay Hospital — Torquay, United Kingdom
• Hillingdon Hospital — Uxbridge, United Kingdom