Parnaparin vs Aspirin in the Treatment of Retinal Vein Occlusion
Status:
Terminated
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
Retinal vein occlusion (RVO) is the second commonest retinal disease after diabetic
retinopathy, and is a common cause of unilateral visual loss. There are two aims in the
management of RVO: the identification of modifiable risk factors and their medical management
and the recognition and management of sight-threatening complications. The management of the
disease includes laser therapy and the control of systemic associated diseases. Many other
treatments have been proposed but there is no evidence on their efficacy in modulating the
outcome of branch or central RVO. There are currently no adequate clinical trials that have
evaluated the efficacy and safety of antithrombotic agents in this setting. Antiplatelet
agents are frequently used in clinical practice. Anticoagulant drugs, either heparins or
coumarins, are also used in this setting as they represent the first line therapy for the
treatment of venous thromboembolism. Aim of this randomized controlled study is to to compare
the efficacy and safety of aspirin and of a low molecular weight heparin, parnaparin, in the
treatment of RVO. Study treatment is administered for 3 months. Primary end-point of the
study is the incidence of functional worsening of the eye with RVO at 6 months. Secondary
efficacy outcomes are the following: proportion of cases requiring laser treatment because of
the extension of the ischemic lesion and/or the presence of neovascularisation and/or macular
oedema, incidence of recurrent RVO objectively documented by fluorescein angiography. Safety
outcomes are defined by the incidence of major and minor bleeding events.