RCT of Avastin in ischaemic diabetic macular oedema (DIME Study)v 1.8

• Research type

  Research Study

• Full title

  Randomised Controlled Trial of Intravitreal therapy with Avastin compared to Observation in Patients with Diabetic Ischaemic Macular Oedema ‘The DIME study’

• IRAS ID

  26471

• Contact name

  Miss Narciss Okhravi

• Sponsor organisation

  Moorfields Eye Hospital NHS Foundation Trust

• Eudract number

  2011-003304-20

• Research summary

  Patients with more advanced diabetic macular oedema (DME) can develop ischaemic changes at the centre of the macula which means that our gold-standard treatment for DME i.e. laser therapy may become ineffective or unsafe. These patients form a large cohort of individuals (approximately 5% of our clinic diabetic patients) and have a mixed clinical picture with both macular oedema (swelling of the retina which impairs vision) and macular ischaemia (severely compromised blood supply to the centre of the retina) and are said to be suffering with diabetic ischaemic macular oedema, (i.e. DIME). There is no established treatment which is of proven benefit for this group of patients, and over the years they are simply monitored in the clinic. A gradual decline in visual function occurs resulting in the patients being registered as legally blind. Clinical benefit from a series of Avastin injections, into the eye, is expected; i.e. that patients maintain better vision for longer. We anticipate seeing no evidence of toxicity attributable to the drug. A control group is thus very important as it will give us a much needed natural history study of such eyes and allow us to compare the results of the treated patients with DIME to those who have not received any treatment (current clinical management). 84 eyes of 84 patients will be recruited via the Medical Retina service clinics at Moorfields Eye Hospital and outreach services. Patients will be randomised into two groups and followed up for 12 months. The team is well placed to undertake this research effectively and safely, whilst measuring effectiveness, safety, assessing health economic costings and documenting changes to the patients?? quality of life. The information from this project, which will be the very first randomised clinical trial in this clinical situation, will inform evidence-based decisions in everyday clinical practice.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0732

• Date of REC Opinion

  9 May 2012

• REC opinion

  Favourable Opinion