FOCUS - semaglutide effect on diabetic retinopathy

• Research type

  Research Study

• Full title

  Long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes

• IRAS ID

  258369

• Contact name

  Sobha Sivaprasad

• Contact email

  sobha.sivaprasad@nhs.net

• Sponsor organisation

  Novo Nordisk Ltd

• Eudract number

  2017-003619-20

• Duration of Study in the UK

  6 years, 0 months, 14 days

• Research summary

  While it is well-established that long-term good glycaemic control will reduce the risk of diabetic retinopathy development and progression, intensification of glycaemic control has also been associated with an initial worsening of diabetic retinopathy. This phenomenon is known as “early worsening”. The rationale of this trial is to establish the long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes (T2D) using validated and standardised ophthalmic assessments. This trial is a post-authorisation safety study (PASS) conducted as a commitment to the European Medicines Agency.
  This trial is a randomised, double-masked, parallel-group, placebo-controlled trial comparing the effects of semaglutide versus placebo on diabetic retinopathy progression each administered s.c. once-weekly, and both added to standard-of-care in subjects with inadequately controlled T2D. Subjects will be randomised 1:1 to receive either semaglutide or placebo.

  To ensure a broad trial population still consisting of a sufficient number of subjects with diabetic retinopathy and treated with insulin, a minimum T2D duration of at least 10 years is required. Since subjects with non-proliferative diabetic retinopathy have the highest likelihood of being able to meet the primary endpoint, randomisation of subjects with no diabetic retinopathy or with microaneurisms only (ETDRS DRSS level 10 and 20) at baseline will be stopped if the group constitutes ≥ 10% of the expected total number of the randomised subjects. Similarly, randomisation of subjects with very advanced diabetic retinopathy, i.e. proliferative diabetic retinopathy (ETRDS DRSS level 61 to 75) will be stopped if this group constitutes ≥ 10 % of the expected total number of the randomised subjects. The randomisation of the subjects will be stratified at baseline according to diabetic retinopathy severity of the worse eye

• REC name

  London - South East Research Ethics Committee

• REC reference

  19/LO/0081

• Date of REC Opinion

  25 Jan 2019

• REC opinion

  Favourable Opinion