Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment. (PNPRO_HC)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status and phase

Unknown

Phase 2

Conditions

Central Retinal Vein Occlusion, Non-Ischemic

Treatments

Drug: Hydroxycarbamid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02957760

P15-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both sexes of at least 45 years of age.
with social protection
Presenting CRVO for less than 1 month duration
With a decrease of visual acuity and with the best corrected visual acuity lower than 6/10 (73 ETDRS letters)
Signature of informed consent

Exclusion criteria

predictable lack of compliance to the protocol
monophtalmic patient or any ocular history or condition that could interfere with the study course or results interpretation.
active systemic disease
sickle cell disease
myeloproliferative disease
myelosuppression
kidney or liver insufficiency
ongoing treatment with hydroxycarbamide or anticoagulant
Pregnancy, breast-feeding, no efficient contraception (for both sexes)
wish of paternity (for males of al least 45 years of age)