EUROCONDOR

• Research type

  Research Study

• Full title

  Neurodegeneration as an early event in the Pathogenesis of Diabetic Retinopathy: A multicentric, prospective, phase II-III, randomised controlled trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest diabetic retinopathy.

• IRAS ID

  104869

• Contact name

  Simon Harding

• Sponsor organisation

  BCN Peptides S.A.

• Eudract number

  2012-001200-38

• Research summary

  Diabetic retinopathy (DR) is the leading cause of blindness among working age people. It is a complication of diabetes which affects the retina, the light sensitive tissue of the eye. Early stages of DR give no symptoms but later stages require treatment to prevent blindness. DR is usually considered to be a disease of the small retinal blood vessels .There is growing evidence that damage to the neural (nerve) layers of the retina (neurodegeneration) happens early in the development of DR. We hypothesise that drug therapies based on protection of the neural layers (neuroprotection) may prevent the development and progression of the early stages of DR. This is the first clinical trial to test the potential of neuroprotective eye drops to prevent DR or prevent its very early stage from progressing further. 450 people will be recruited from 11 ophthalmology clinics around Europe, four of which will be in the UK. Participants will be randomly allocated to receive one of three different eyedrops: containing one of two different neuroprotective drugs (brimonidine or somatostatin) or placebo. Brimonidine is licensed for glaucoma and somatostatin eyedrops have been developed for this study. Participants will be asked to put one drop into each eye twice a day for the duration of the trial (96 weeks). At the beginning of the study and at weeks 24, 48, 72 and 96, participants will undergo various imaging and visual tests to assess the structure and function of their retina and to check for side effects. The results will be compared between participants receiving the drugs and placebo, to assess whether either or both of the drugs have an effect better than placebo in preventing the progression of DR. In addition 10 volunteers at each site will undergo a single subset of tests to provide data on normals.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0526

• Date of REC Opinion

  4 Sep 2012

• REC opinion

  Further Information Favourable Opinion