Dexamethasone vs. Ranibizumab in Patients with Diabetic Macula Oedema

• Research type

  Research Study

• Full title

  A Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) to Ranibizumab in Patients with Diabetic Macula Edema

• IRAS ID

  97293

• Contact name

  Paulo Stanga

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2011-005631-20

• Clinicaltrials.gov Identifier

  NCT01492400

• Research summary

  This study is designed to compare the safety and efficacy during 12 months of treatment of 700 æg DEX PS DDS with ranibizumab 0.5 mg, delivered via injection into the back of the eye. The study will be performed in patients with diabetic macula edema (DME). The aim of this study is to demonstrate that the DEX PS DDS administered every 5 months will reduce DME similarly as ranibizumab, but will show a longer duration of the treatment effect and therefore require less frequent injections into the back of the eye.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/0372

• Date of REC Opinion

  13 Aug 2012

• REC opinion

  Further Information Favourable Opinion