Diabetic macular oedema & ranibizumab; detailed functional analysis

• Research type

  Research Study

• Full title

  Diabetic macula oedema: A prospective randomised study comparing the detailed functional and anatomical changes of repeated pan anti-VEGF therapy with ranibizumab versus conventional macular laser therapy.

• IRAS ID

  48513

• Contact name

  Philip Hykin

• Sponsor organisation

  Moorfields Eye Hospital

• Eudract number

  2010-021722-35

• ISRCTN Number

  n/a

• Research summary

  Diabetic retinopathy is the leading cause of legal blindness and visual impairment in the working-age population in England and Wales. Diabetic macular oedema is an abnormal collection oflud in the macular region of patients with diabetic eye disease. The only proven modalities to reduce the risk of visual loss in this condition are intensive blood sugar control, blood pressure control and macular laser therapy. Due to the modest outcomes with laser therapy, new treatment approaches are being sought.This study is a randomised clinical trial which will compare the effect of repeated intravitreal injections of ranibizumab on the anatomical structure and function of the retina, compared with the changes seen following conventional laser therapy.Ranibizumab is an inhibitor of VEGF, a small molecule released by the retina and implicated in the development of diabetic macular oedema. It is delivered by injection into the eye using a very fine needle. There is extensive experience of the use of ranibizumab in the treatment of age-related macular degeneration. There are now also encouraging results from early studies examining the use of ranibizumab to treat diabetic macular oedema.Patients with diabetic maculopathy who have been shown to have active macular oedema would be eligible for this trial. Thirty-six participants will be randomised either to receive repeated ranibizumab injections or conventional laser therapy. This study is being carried out at Moorfields Eye Hospital. The trial duration is 12 months and will involve a number of visits for examination, tests and treatment.This study is being sponsored by Moorfields and funded by an unrestricted grant from Novartis (which means that Novartis do not have any control over the study - neither in the way it is conducted, nor with the publishing rights).

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/40

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion