Ranibizumab for DMO PRP trial (RDP trial)
Research type
Research Study
Full title
Randomized trial of wide-field guided PRP for diabetic macular oedema (DMO) treated with Ranibizumab. (Ranibizumab for DMO PRP trial (RDP trial))
IRAS ID
121940
Contact name
James Talks
Contact email
Sponsor organisation
Newcastle Hospitals NHS foundation Trust
Research summary
Ranibizumab is licensed for the treatment of diabetic macular oedema. It is given as an injection into the eye. Whilst it can work well a large number of injections maybe needed over a number of years. Ranibizumab works by blocking vascular endothelial growth factor (VEGF). The main pathology causing the oedema maybe due to changes in the central retinal circulation but it is possible that peripheral ischaemia, which is a poor circulation in the peripheral areas of the retina, leads to an increase in VEGF levels and so drives the recurrence of macular oedema, at least in a subset of patients. It has only recently become possible to visualize the degree of peripheral ischaemia with wide-field fluorescein angiography (wFFA). It is therefore possible to target the area of ischaemia with peripheral laser that might reduce VEGF levels and so help lead to stabilization of the macular oedema and so make the treatment more acceptable for patients, more cost effective and lead to better long term visual results. In this study patients with macular oedema and peripheral retinal ischaemia will be treated with ranibizumab but randomized to additional retinal laser. The main outcomes will be the length of time a patient does not require an injection, after the initial loading phase. Number of injections in a year and the difference in visual acuity at the end of one year.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0197
Date of REC Opinion
13 Sep 2013
REC opinion
Further Information Favourable Opinion