Ranibizumab in visual impaired patients due to macular edema (CRVO).

• Research type

  Research Study

• Full title

  A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)

• IRAS ID

  88852

• Contact name

  Philip Hykin

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-002350-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is an open-label, phase IIIb, single arm study sponsored by Novartis. The investigational treatment in this study is 0.5 mg ranibizumab administered PRN by intravitreal injections. There is no control treatment. Ranibizumab blocks a molecule that researchers believe triggers growth and leaking of blood vessels in the retina. Use of ranibizumab helps prevent further damage to the eye and to vision. It may even repair some of the damage that has occurred already. Ranibizumab (??Lucentis©??) is approved by the Medicines and Healthcare products Regulatory Agency (MHRA), health authorities in Europe and the United States for the treatment of people with central retinal vein occlusion (CRVO). The benefits of ranibizumab for treating macular oedema caused by CRVO are known, but the benefits of treating it on the schedule in this study are not established. The purpose of this study is to determine if the drug ranibizumab (??Lucentis©??) is safe and has beneficial effects in people who have loss of vision because of macular oedema caused by CRVO. About 350 patients will join in this study at about 70 centres in approximately 20 countries. Approximately 35 participants will be recruited in the UK. Each patient in the study will participate for 2 years. If participant join the study, they will be asked to come to the study doctor??s clinic 15 times over the first year of the study and up to 12 planned visits in the second year. There may be fewer visits in the second year, depending on how well their eye condition responds to the treatment. The study involves procedures including: medical history, eye tests, questionnaires, pregnancy test, vital signs, review of medications, drug administration, antibiotic medication administration, post injection safety, adverse events.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0024

• Date of REC Opinion

  24 Feb 2012

• REC opinion

  Further Information Favourable Opinion