Efficacy and safety of Ozurdex vs Lucentis in patients with BRVO

• Research type

  Research Study

• Full title

  A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of Ozurdex Versus Lucentis in Patients with Branch Retinal Vein Occlusion

• IRAS ID

  79817

• Contact name

  Adnan Tufail

• Sponsor organisation

  Allergan Pharmaceuticals Ireland

• Eudract number

  2010-023900-29

• ISRCTN Number

  not issued

• Research summary

  Macular oedema (ME) is the swelling or thickening of the macula due tflud accumulation. Retinal vein occlusive (RVO) disease is one of the most common diseases associated with ME and significant vision loss. Ozurdex and Lucentis have both been approved for treatment for RVO. Because the populations of RVO subjects participating in studies with Ozurdex were different from those in studies with Lucentis, it is difficult to directly compare the results of the 2 treatments. The purpose of this 12 month, multicentre, randomised study is to directly compare the safety and efficacy of Ozurdex and Lucentis in the same population of patients with branch retinal vein occlusion (BRVO)flurescein Angiograms and Optical Coherence Tomography (OCT) images collected at the screening visit will be sent to a central reading centre (CRC). Once eligibility has been confirmed by the CRC and all other inclusion and exclusion criteria have been met at the baseline visit, all eligible subjects will be randomised at a 1:1 ratio to receive Ozurdex or Lucentis. Approximately 400 subjects, 200 per treatment arm, will be enrolled at approximately 40 sites. This study will enrol subjects with BRVO in at least one eye.Ozurdex will be administered at day 1 and month 5. Subjects may receive an additional treatment at month 10 or month 11 based on pre-defined retreatment criteria. Lucentis will be administered at day 1 and monthly through month 5. Subjects may receive additional treatments at month 6 through month 11 based on pre-defined retreatment criteria. After randomisation, subjects will be followed for 12 months. There will be 15 study visits including the following: screening, baseline (day 1), day 7 and monthly visits from month 1 through month 12. The primary efficacy endpoint is the mean change in best corrected visual acuity (BCVA) between baseline and month 12.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1023

• Date of REC Opinion

  23 Aug 2011

• REC opinion

  Further Information Favourable Opinion