Ranibizumab vs dexamethasone in branch retinal vein occlusion

• Research type

  Research Study

• Full title

  A 6-month, multicentre, randomised, double-masked phase IIIb study comparing the efficacy and safety of Lucentis (ranibizumab) intravitreal injections versus Ozurdex (dexamethasone) intravitreal implant in patients with visual impairment due to macular oedema following branch retinal vein occlusion (BRVO)

• IRAS ID

  84318

• Contact name

  Christopher Brittain

• Sponsor organisation

  Novartis Pharma GmbH

• Eudract number

  2011-001019-30

• Research summary

  Retinal vein occlusion (RVO) is usually the result of a blockage forming in a blood vessel in the retina, which is the light-sensitive layer at the back of the eye. In BRVO (branch retinal vein occlusion), the blockage occurs where a branch retinal vein crosses a branch retinal artery. Such blockages can lead to severe damage of the retina and blindness, due to ischaemia (restriction in blood supply) and oedema (swelling). The macula is the central portion of the retina responsible for sharp vision. Swelling of the macula, or macular oedema, is the most common cause of visual impairment in patients with BRVO. Previous clinical studies have shown improvements in vision with medications, such as ranibizumab and dexamethasone, that block a chemical signal called vascular endothelial growth factor (VEGF), which stimulates new blood vessel growth and leakage in the eye. The aim of this study is to compare monthly injections of ranibizumab with a single dexamethasone implant injected into the eye to see if patients benefit more from ranibizumab or dexamethasone over a 6 month period.Patients will visit the hospital clinic 8 times over the 6-month study period, and the main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography anflurescein dye tests, ultrasound of the eye, measurement of pressure inside the eye, blood pressure, pulse, blood and urine tests and completion of health and vision-related questionnaires.Approximately 240 patients will be treated from around 60 centres in the European Union, of which around 75 patients will be included from 15 - 20 sites in the UK.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  11/LO/1256

• Date of REC Opinion

  3 Oct 2011

• REC opinion

  Further Information Favourable Opinion