Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment. (PNPRO_HC)
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|ClinicalTrials.gov Identifier: NCT02957760|
Recruitment Status : Unknown
Verified November 2016 by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Recruitment status was: Recruiting
First Posted : November 8, 2016
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Central Retinal Vein Occlusion, Non-Ischemic||Drug: Hydroxycarbamid||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2017|
- Drug: Hydroxycarbamid
20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).Other Name: siklos
- retinal capillary non-perfusion [ Time Frame: 3 months ]
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.
- retinal capillary non-perfusion [ Time Frame: 2 weeks, 2 months and 6 months ]Same criteria of retinal non perfusion as for primary end point
- Hydroxycarbamide safety - 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 ]HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957760
|Contact: Laurent Vinetfirstname.lastname@example.org|
|Principal Investigator:||Jean-François Girmens||CHNO des Quinze-Vingts|