Extension to use of RFB002 in patients with diabetic macular oedema

• Research type

  Research Study

• Full title

  An extension to the randomized, double-masked, multicenter, laser-controlled Phase III study assessing the efficacy and safety of ranibizumab(intravitreal injections) as adjunctive and mono-therapy in patients with visual impairment due to diabetic macular oedema

• IRAS ID

  35186

• Contact name

  Aaron Osborne

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2008-007467-17

• ISRCTN Number

  Not available

• Research summary

  This is a 24-month, open-label, multi-center extension study in DME patients, who have completed 12-months of study assessments in RESTORE (RFB002D2301). Patients will be treated with ranibizumab (0.5 mg) intravitreal injections. The eye to be treated will be the same eye that was selected as study eye in the core study. Laser treatment may be administered in addition according to the investigators decision following ETDRS (Early Treatment Diabetic Retinopathy Study) guidelines.Patients will have their baseline visit on the same day as their final visit of the core study (Visit 14) and attend for a maximum of 25 visits over the 24 month treatment period. The study will involve a maximum of two patients at two centres in the UK.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/48

• Date of REC Opinion

  17 Dec 2009

• REC opinion

  Further Information Favourable Opinion