Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hopital Universitaire Robert-Debre | OTHER |
| Institut National de la Transfusion Sanguine | OTHER |
| Keyrus Biopharma | OTHER |
| For Drug Consulting |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxycarbamid | Drug | 20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| retinal capillary non-perfusion | Same criteria of retinal non perfusion as for primary end point | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Vinet | Contact | +33140021126 | lvinet@15-20.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-François Girmens | CHNO des Quinze-Vingts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHNO des Quinze-Vingts | Recruiting | Paris | 75012 | France |
Not provided
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
| OTHER |
| Theravia | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters. |
| 2 weks, 2 months, 3 months and 6 months |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |