Clinical trial NCT02957760: Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
Official title: Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Central Retinal Vein Occlusion, Non-Ischemic
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
Collaborators: name: Hopital Universitaire Robert-Debre
name: Institut National de la Transfusion Sanguine
name: Keyrus Biopharma
name: For Drug Consulting
name: Theravia
First posted: 2016-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: retinal capillary non-perfusion
timeFrame: 3 months
Secondary outcomes:
measure: retinal capillary non-perfusion
timeFrame: 2 weeks, 2 months and 6 months
measure: Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.
timeFrame: 2 weks, 2 months, 3 months and 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: CHNO des Quinze-Vingts
Study officials:
affiliation: CHNO des Quinze-Vingts
name: Jean-François Girmens
role: PRINCIPAL_INVESTIGATOR
References: