drugset / Trial / NCT01030770

Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

NCT01030770

Phase 2/3 Completed 25 enrolled King's College Hospital NHS Trust Novartis · collab
RandomizedSingle-groupTriple-blindTreatment

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.

Timeline

Start
2010-07
Primary completion
2015-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal

Indications