RETAIN-ranibizumab for patients with diabetes mellitus

• Research type

  Research Study

• Full title

  A 2 year randomized, single-masked, multicentre, controlled phase IIIb trial assessing the Efficacy and safety of 0.5 mg ranibizumab in two “treat and extend” treatment algorithms vs. 0.5 mg ranibizumab as needed in patients with macular edema and visual Impairment secondary to diabetes mellitus

• IRAS ID

  56968

• Contact name

  Clare Bailey

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-019795-74

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Diabetes Mellitus (DM) is the most common endocrine disease, affecting approximately 2-5% of the world??s population. Diabetic retinopathy (DR) and diabetic macular oedema (DME) secondary to DR are common complications in patients with diabetes, and may have a sudden and debilitating impact on visual acuity (VA).Vision-threatening DME is characterised by swelling of the central part of the retina and arises from breakdown of the blood-retinal barrier (BRB), which may be brought about in part by a growth factor known as vascular endothelial growth factor (VEGF). When VEGF was measured in the eyes of patients with different diseases involving macular oedema, patients with DME showed the highest intraocular (in eye) VEGF concentrations. Laser photocoagulation is currently the standard treatment used to prevent progression of vision loss in DME patients. However, it does not improve vision on average and a percentage of patients have been shown to still lose vision at the end of a 3 year period.Novartis© are responsible for developing the study drug (ranibizumab), which is an antibody fragment that selectively binds to VEGF, and is approved for the treatment of age-related macular degeneration (AMD) in numerous countries. In AMD studies, ranibizumab led to rapid vision improvement and function. It is hoped that this study will demonstrate the ability of ranibizumab to address a main cause of DME, by inhibiting in-eye VEGF.This is a randomised, controlled trial which means that patients will be randomly assigned to one of three treatment arms;?½ combination of 0.5mg ranibizumab ??Treat and Extend? laser?½ 0.5mg ranibizumab ??Treat and Extend? alone?½ 0.5 ranibizumab alone given as needed (control)This is a multicentre study which will take place at approximately 79 sites across Europe and Russia. It is anticipated that around 345 patients will be enrolled, with 60 from the UK.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/68

• Date of REC Opinion

  30 Sep 2010

• REC opinion

  Favourable Opinion