Efficacy & Safety of RG7774 in Patients with Diabetes Mellitus Type1&2

• Research type

  Research Study

• Full title

  A randomized, double-masked, 48-week parallel-group, placebo-controlled, proof-of-concept study to investigate the efficacy and safety of RG7774 in patients with Diabetes Mellitus Type 1 or Type 2 with treatment-naïve diabetic retinopathy.

• IRAS ID

  278100

• Contact name

  Ian Andrew Pearce

• Contact email

  Ian.Pearce@liverpoolft.nhs.uk

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2019-002067-10

• Clinicaltrials.gov Identifier

  NCT04265261

• Duration of Study in the UK

  2 years, 4 months, 2 days

• Research summary

  Research Summary

  RG7774 is a synthetic small molecule, highly selective and potent cannabinoid 2 (CB2) receptor agonist intended for the oral treatment of diabetic retinopathy (DR). Activation of CB2 receptor by RG7774 has shown to produce anti-inflammatory effects in the eye consequently preserving endothelial barrier function. The principle aim of study BP41321 is to assess the safety, tolerability and the effect of oral administration of RG7774 on the severity of DR in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision. The secondary objectives are to further evaluate the potential of RG7774 to prevent progression of DR and to assess the effect of RG7774 on best-corrected visual acuity (BCVA). This is a phase II, multi-center, randomized, three-parallel-group, placebo-controlled, doublemasked, proof-of-concept study. Participants will receive RG7774 or placebo for up to 36 weeks.

  Participants will be randomized in equal proportions to one of the following treatment groups:
  -Group A: placebo oral once daily (QD)
  -Group B: 30 mg RG7774 oral QD
  -Group C: 200 mg RG7774 oral QD

  The total duration of the study for each participant will be up to 52 weeks divided as follows:
  -Screening (from Day 28 to Day 7).
  -Baseline/ Day 1 (1 day).
  -Study treatment period with fixed dose (36 weeks).
  -Safety and efficacy follow-up period (28 days after last dose: Week 40 visit).
  -Long-term follow-up period (8 weeks: from Week 40 visit to Week 48 visit).

  Summary of Results

  This study was done to test how well Vicasinabin works to treat DR in people with type 1 or 2 diabetes mellitus, good vision, and who have not yet been treated for DR. Researchers also looked at how safe Vicasinabin is.
  In this study, people were given either Vicasinabin (the medicine being studied), OR a placebo – it was decided by chance which treatment each person was given.
  This study included 139 people in 6 countries.
  The main findings were that: Vicasinabin does not help improve damaged blood vessels at the back of the eye in people with DR 30mg and 200mg doses of Vicasinabin are safe enough to be given to people with DR (Diabetic Retinopathy). No person taking Vicasinabin or the placebo had serious unwanted effects related to study treatment.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  20/LO/0348

• Date of REC Opinion

  27 Jul 2020

• REC opinion

  Further Information Favourable Opinion