Central Retinal Vein Occlusion, Non-Ischemic Clinical Trial
Official title:
Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine
introduction : The central retinal vein occlusion (CRVO) is a major cause of ocular
morbidity, depending in particular on the occurrence and extent of retinal ischemia by
capillary occlusion. There is no effective systemic treatment of this condition. An increase
in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO,
correlated with overexpression of membrane phosphatidylserine.
Hypothesis : Hydroxycarbamide (HC) by reducing the erythrocyte adhesion to the endothelium
may prevent or delay the onset of retinal capillary non-perfusion in patients with CRVO.
Primary objective: To assess the efficacy at 3 months of treatment with HC on retinal
capillary perfusion in patients with a recent CRVO.
Secondary Objectives: To evaluate the safety of the treatment, the efficacy to 6 months on
retinal perfusion of the treatment with HC (HC peak effect on the red cell adhesion in
vitro), and the biological effects of HC, in particular on adhesion to endothelium and
erythrocyte hemorheological parameters.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment