INSITE DME

• Research type

  Research Study

• Full title

  Treat & Extend versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

• IRAS ID

  1007301

• Contact name

  Sobha Sivaprasad

• Contact email

  sobha.sivaprasad@nhs.net

• Sponsor organisation

  Moorefields Eye Hospital

• Clinicaltrials.gov Identifier

  NCT05610319

• Research summary

  Diabetic Macular Edema (DME) is a leading cause of vision loss related to diabetic retinopathy. Clinically anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard of care for treatment of DME. The current standard of care for administration of anti-VEGF injections requires patients to undergo frequent clinical examinations and intravitreal injections. This imposes a significant burden on patients, caregivers, treating physicians and the health care system
  Alternative, treatment algorithms have been assessed with the goal of minimizing the burden and costs of DME management, such as the treat and extend (T&E) approach.
  This two-armed, parallel, non-inferiority randomized controlled trial determines if a 4-week Treat &Extend regime up to 24Weeks with faricimab versus fixed dosing at 8Weeks with faricimab produces non- inferior outcomes.
  Approximately 446 participants will be recruited globally and 50 from UK From 11 participating sites over 100 weeks .The participants will be randomized into the study globally in a 1:1 ratio into treat and extend arm and fixed dose arm.
  The study is funded by F.Hoffman La Roche
  Secondary Objectives The secondary objectives are to determine the effect of a 4-week pragmatic treat and extend regime up to Q24W with faricimab versus fixed dosing at Q8W on the following:
  1) the proportion of participants with a 2-step improvement in diabetic retinopathy severity score from baseline to week 100; 2) the proportion of participants with a 3-step improvement in diabetic retinopathy severity score from baseline to week 100; 3) the change in central subfield thickness on OCT from baseline to week 100; 4) the change in vision-related quality of life

• REC name

  HSC REC A

• REC reference

  23/NI/0067

• Date of REC Opinion

  8 Nov 2023

• REC opinion

  Further Information Favourable Opinion