Ranibizumab Versus Verteporfin PDT in Pathological Myopia

• Research type

  Research Study

• Full title

  A 12 month, phase III, randomized, double-masked, multicenter, active-controlled study to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab vs. verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia.

• IRAS ID

  64435

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-021662-30

• Clinicaltrials.gov Identifier

  01217944.

• Research summary

  This is a study to compare two different treatment regimes of ranibizumab (also known as Lucentis, a type of drug known as a "growth factor blocker") with the current standard therapy of verteporfin photodynamic therapy (vPDT) in a disease known as choroidal neovascularisation secondary to pathological myopia. The disease under investigation involves the growth of new blood vessels in the back of the eye (the retina). These vessels leak fluid and blood, causing a loss of vision. Those who are very short sighted, or myopic, are at increased risk of this condition. The condition is thought to be the leading cause of visual impairment in younger patients worldwide. The current standard therapy, verteporfin with photodynamic therapy (vPDT), involves injecting a drug into a vein in the arm and then activating the drug by shining a laser at the diseased area in the eye. This treatment works well to stabilise vision, but does not consistently improve vision. The drug under investigation, ranibizumab, is a growth factor blocker injected directly into the eye, and has been used to successfully treat a similar disease known as wet age related macular degeneration (wet AMD). The aim of this study is to compare the outcomes of two treatments, and also to help establish the best treatment regime for ranibizumab i.e. how often ranobizumab should be given, in order to help optimise patient outcomes. The study will be run at approximately 80 centres worldwide, with 6 of these being in the UK. Approximately 18 patients from the UK are expected to participate.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/53

• Date of REC Opinion

  17 Dec 2010

• REC opinion

  Further Information Favourable Opinion