Trial | NCT02957760  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    hydroxyurea ...

  • Study Participants

    30
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.
Study Started
Dec 31
2015
Primary Completion
Aug 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Nov 28
2016
Estimate

Drug Hydroxycarbamid

20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).

  • Other names: siklos

Criteria 

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)
No Results Posted