Open label study of ranibizumab in Diabetic Macular Oedema (RELIGHT)

• Research type

  Research Study

• Full title

  Ranibizumab treatment of diabetic macular oedema with bimonthly monitoring after a phase of initial treatment. A UK, 18-month, prospective, open-label, multicentre, single-arm, Phase IIIb study, with 12-month primary endpoint, assessing the efficacy and safety of Lucentis (ranibizumab) in patients with visual impairment due to diabetic macular oedema.

• IRAS ID

  62380

• Eudract number

  2010-022616-39

• Clinicaltrials.gov Identifier

  01257815

• Research summary

  Diabetic macular oedema (DMO) is a common complication associated with diabetic retinopathy and can lead to severe visual loss. The condition damages the small blood vessels in the eye's light-sensitive retinal tissue, which become leaky and swell. If these damaged blood vessels begin to leak near the centre of the retina, known as the macula, the surrounding area swells which can lead to vision loss if left untreated. Laser treatment of the retina has been the standard of care for diabetic macular oedema. However, some small studies have since found benefits in medications that block a chemical signal called vascular endothelial growth factor (VEGF), which stimulates blood vessel growth. Repeated eye injections of anti-VEGF medications, such as ranibizumab (Lucentis), may prevent blood vessels from leakinflud and causing macular oedema. This study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for three months then two-monthly follow-up to the primary end-point at 12 months. The study will continue with bi-monthly follow-up out to 18 months. Laser treatment will be permitted after 6 months. The aim of this study is to determine if this treatment regimen is effective and safe in patients with visual impairment due to DMO. Patients will visit the hospital clinic 16 times in total over the 18-month study period, and the main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography, measurement of pressure inside the eye, blood pressure, pulse, blood tests and completion of health and vision-related questionnaires. Approximately 115 patients will be treated from around 15-20 sites within the UK.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  10/H0301/52

• Date of REC Opinion

  30 Nov 2010

• REC opinion

  Further Information Favourable Opinion