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

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ClinicalTrials.gov Identifier: NCT02957760
Recruitment Status : Unknown
Verified November 2016 by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Recruitment status was:  Recruiting
First Posted : November 8, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
Robert Debré Hospital
Institut National de la Transfusion Sanguine
Keyrus Biopharma
For Drug Consulting
ADDMEDICA SASA
Information provided by (Responsible Party):
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion, Non-Ischemic Drug: Hydroxycarbamid Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
Study Start Date : December 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Intervention Details:
  • Drug: Hydroxycarbamid
    20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).
    Other Name: siklos


Primary Outcome Measures :
  1. retinal capillary non-perfusion [ Time Frame: 3 months ]

    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.


Secondary Outcome Measures :
  1. retinal capillary non-perfusion [ Time Frame: 2 weeks, 2 months and 6 months ]
    Same criteria of retinal non perfusion as for primary end point

  2. Hydroxycarbamide safety - visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters. [ Time Frame: 2 weks, 2 months, 3 months and 6 months ]
    HC effect on visual acuity and retinal thickness. Biological in vitro effects on erythrocyte adhesion to vascular endothelium and various haemorheological parameters.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957760


Contacts
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Contact: Laurent Vinet +33140021126 lvinet@15-20.com

Locations
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France
CHNO des Quinze-Vingts Recruiting
Paris, France, 75012
Contact: Laurent Vinet    +33140021126    lvinet@15-20.fr   
Contact: Romain Duvernois    +33140021124    rduvernois@15-20.fr   
Sponsors and Collaborators
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Robert Debré Hospital
Institut National de la Transfusion Sanguine
Keyrus Biopharma
For Drug Consulting
ADDMEDICA SASA
Investigators
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Principal Investigator: Jean-François Girmens CHNO des Quinze-Vingts

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Responsible Party: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
ClinicalTrials.gov Identifier: NCT02957760     History of Changes
Other Study ID Numbers: P15-01
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases