Open-label study of ranibizumab in choroidal neovascularisation

• Research type

  Research Study

• Full title

  A phase II, open-label, multicentre, 12 month study to evaluate the efficacy and safety of ranibizumab (0.5 mg) in patients with choroidal neovascularization secondary to pathological myopia (REPAIR).

• IRAS ID

  32991

• Contact name

  Aaron Osborne

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2009-014854-14

• ISRCTN Number

  n/a

• Research summary

  Pathological myopia (PM) is a progressive condition which causes excessive lengthening of the eyeball, resulting in extreme short-sightedness. In 5-11% of people with this condition, a sight-threatening complication called choroidal neovascularisation (CNV) develops. CNV is the growth of new, leaky blood vessels below and into the retina, which leaflud and blood causing loss of vision. Current treatment of this condition with photodynamic therapy and verteporfin (vPDT) is less than optimal, and has shown only short-term stabilisation, rather than improvement, of vision. Ranibizumab is licensed for the treatment of age-related macular degeneration associated with CNV, where rapid improvements of vision have been widely demonstrated. Preliminary case studies have shown significant improvements in visual acuity when ranibizumab is given to patients with PM. The aim of this study is to determine whether ranibizumab is an effective and safe treatment in patients with CNV secondary to PM using a guided, individualised as-needed dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria. Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography anflurescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires. Approximately 64 patients will participate in this study at 8 - 14 hospital sites in the UK only.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/56

• Date of REC Opinion

  17 Nov 2009

• REC opinion

  Further Information Favourable Opinion