Ranibizumab in visual impaired patients due to macular edema(BRVO)

• Research type

  Research Study

• Full title

  A 24-month, phase IIIb, open-label, randomized, activecontrolled, 3-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 or with adjunctive laser photocoagulation in comparison to laser photocoagulation in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)

• IRAS ID

  88851

• Contact name

  Philip Hykin

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-002859-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is an open-label, phase IIIb, randomised, 3 arm, PRN dosing regimen study sponsored by Novartis. Participants will be assigned to be treated with either 0.5 mg ranibizumab intravitreal injections alone, laser treatment alone, or a combination of ranibizumab and laser treatment. Patients in this study will be assigned in a 2:1:2 ratio to these treatment arms. Ranibizumab (??Lucentis©??) is approved by the MHRA, health authorities in Europe and the United States for the treatment of people with branch retinal vein occlusion (BRVO). The benefits of ranibizumab or laser treatment for treating macular oedema caused by BRVO are known, but the benefits of treating it on the schedule for this study are not established. The benefits of using laser together with ranibizumab are also not established. The purpose of this study is to determine if the study drug ranibizumab is safe and has beneficial effects in people who have loss of vision due to macular oedema caused by BRVO. This study also aims to find out which treatment is most effective for people with this eye condition. About 450 patients will join in this study at about 70 centers in approximately 20 countries. Approximately 70 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, laser treatment, antibiotic medication administration, post injection safety, adverse events.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0025

• Date of REC Opinion

  24 Feb 2012

• REC opinion

  Further Information Favourable Opinion