RAINBOW
Research type
Research Study
Full title
RAINBOW study: a randomised, controlled study evaluating the efficacy and safety of ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity
IRAS ID
188713
Contact name
Gaelle Enderlin
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-003041-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
During foetal development, the retina develops late in the womb and very premature babies may have incomplete development of the blood vessels needed to provide oxygen to the retina. After birth, blood vessels may develop abnormally causing vision loss/blindness. Retinopathy of prematurity (ROP) affects ~20% of premature babies, is a significant cause of blindness in children in developed and developing countries with ~50,000 children blind from ROP worldwide.
Laser therapy to the eye is the standard treatment for ROP with earlier treatment shown to be more effective, however this is not possible for some patients and usually requires general anaesthesia and good accuracy of visualizing the eye, both difficult to achieve with premature babies.
New blood vessel formation requires a protein called vascular endothelial growth factor (VEGF). Ranibizumab is a drug which is injected into the eye and works by blocking the effects of VEGF to prevent the growth of these abnormal blood vessels.
This is a 24 week open-label study (the study doctor, parent(s)/legal guardian(s) will know which treatment is being received) to compare 2 different doses of ranibizumab (0.1mg and 0.2mg) with standard laser therapy. Patients receiving ranibizumab will have one injection to both eyes at the beginning of the study. Thereafter they can receive up to 2 further injections of ranibizumab in each eye if needed. Patients receiving laser therapy will receive standard treatment at the beginning of the study. Where unsatisfactory responses to treatment are seen, patients can be switched from their original treatment (i.e. from laser therapy to ranibizumab 0.2mg or from ranibizumab 0.1mg or 0.2mg to laser therapy).
Premature babies with ROP will be included in this study with a target of 6 patients in the UK across 3 sites.
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/1828
Date of REC Opinion
6 Jan 2016
REC opinion
Further Information Favourable Opinion