Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:
United Kingdom25 participantsStarted 2010-07
Plain-language summary
This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease).
It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults (male or female over 18) with Type 1 or Type 2 diabetes mellitus
✓. Grade 2-4 fundus obscuring diabetic vitreous haemorrhage of at least 2 months duration prior to screening in the study eye.
✓. Subjects who have elected to undergo a therapeutic pars plana vitrectomy to clear persistent diabetic vitreous haemorrhage
✓. Best corrected visual acuity from 40 letters (using 4 metre ETDRS visual acuity score) to perception of light in the study eye
✓. Patients able and willing to give written and witnessed informed consent.
Exclusion criteria
✕. The presence of tractional retinal elevation in the study eye, as detected by B mode ocular ultrasound or fundus biomicroscopy.
✕. Other (non-diabetic) cause of vitreous haemorrhage
✕. Other (non-diabetic) retinal vasculopathy in the study eye
✕. Subjects who were listed for vitrectomy for recurrent vitreous haemorrhage alone, and not for persistent vitreous haemorrhage
What they're measuring
1
Number of patients requiring pars plana vitrectomy at week 7.