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

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

Study Overview

• Status: Unknown
• Conditions: Central Retinal Vein Occlusion, Non-Ischemic
• Intervention / Treatment: Drug: Hydroxycarbamid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • CHNO des Quinze-Vingts
    • Contact: Laurent Vinet; Phone Number: +33140021126; Email: lvinet@15-20.fr
    • Contact: Romain Duvernois; Phone Number: +33140021124; Email: rduvernois@15-20.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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): Occurence of at least one direct sign of retinal ischemia: Increase of more than 30% of peripheral retinal non-perfusion on large-field angiography or of the central avascular zone of the retina,; Occurence of at least one indirect sign of retinal ischemia: reperfusion of the aterial iris circle, rubeosis iridis, neovascular glaucoma or abolition of the afferent pupillary reflex.	3 months

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Collaborators: Hopital Universitaire Robert-Debre; ADDMEDICA SASA; Keyrus Biopharma; For Drug Consulting; Institut National de la Transfusion Sanguine
• Investigators: Principal Investigator: Jean-François Girmens, CHNO des Quinze-Vingts

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antisickling Agents; Hydroxyurea
• Other Study ID Numbers: P15-01