A Phase 2 interventional study of Hydroxycarbamid in Central Retinal Vein Occlusion, Non-Ischemic, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Status unknown at 1 site in France. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Phase 2, Interventional, and 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.
282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).
Also known as: siklos
retinal capillary non-perfusion
To assess the percentage of subjects in whom one of the following events will not be observed at W13 (any event being considered as one of the criteria of worsening of retinal capillary non-perfusion): * Occurence of at least one direct sign of retinal ischemia: Increase of more than 30% of peripheral retinal non-perfusion on large-field angiography or of the central avascular zone of the retina, * Occurence of at least one indirect sign of retinal ischemia: reperfusion of the aterial iris circle, rubeosis iridis, neovascular glaucoma or abolition of the afferent pupillary reflex.
Time frame: 3 months
retinal capillary non-perfusion
Same criteria of retinal non perfusion as for primary end point
Time frame: 2 weeks, 2 months and 6 months
Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.
HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.
Time frame: 2 weks, 2 months, 3 months and 6 months
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts