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

NCT ID: NCT02957760

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Central Retinal Vein Occlusion, Non-Ischemic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hydroxycarbamid

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

Intervention Type DRUG

Other Intervention Names

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siklos

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Universitaire Robert-Debre

OTHER

Sponsor Role collaborator

Institut National de la Transfusion Sanguine

OTHER

Sponsor Role collaborator

Keyrus Biopharma

OTHER

Sponsor Role collaborator

For Drug Consulting

OTHER

Sponsor Role collaborator

Theravia

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François Girmens

Role: PRINCIPAL_INVESTIGATOR

CHNO des Quinze-Vingts

Locations

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CHNO des Quinze-Vingts

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurent Vinet

Role: CONTACT

Phone: +33140021126

Email: [email protected]

Facility Contacts

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Laurent Vinet

Role: primary

Romain Duvernois

Role: backup

Other Identifiers

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P15-01

Identifier Type: -

Identifier Source: org_study_id