The DIME Study - Lucentis in Ischaemic Diabetic Macular Oedema

• Research type

  Research Study

• Full title

  Intravitreal Ranibizumab (Lucentis) Therapy in Patients with Diabetic Ischaemic Macular Oedema (DIME)

• IRAS ID

  122950

• Contact name

  Michel Michaelides

• Sponsor organisation

  Research & Development

• Eudract number

  2013-000031-27

• ISRCTN Number

  N/A

• Research summary

  Patients with advanced diabetic macular oedema (DME) can develop poor blood supply (ischaemia) to the centre of the macula which is not amenable to laser therapy. These patients form a large cohort of individuals 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. A gradual decline in visual function occurs resulting in the patients being registered as legally blind. Intraocular injections of Lucentis have been shown by multiple randomised studies to improve visual outcome in patients with DME - however none of these studies specifically investigated the benefit in patients with significant macular ischaemia (DIME). We plan to determine the effectiveness and safety of Lucentis injections in 80 patients with DIME.80 eyes of 80 patients will be recruited via the Moorfields Eye Hospital Medical Retina clinics. Patients will remain in the study for 12 months. The team is well placed to undertake this research effectively and safely, whilst measuring effectiveness, safety, assessing health economic costing and documenting changes to the patients?? quality of life.

• REC name

  London - South East Research Ethics Committee

• REC reference

  13/LO/0188

• Date of REC Opinion

  20 Mar 2013

• REC opinion

  Further Information Favourable Opinion