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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

Tracking Information
First Submitted Date  ICMJE November 4, 2016
First Posted Date  ICMJE November 8, 2016
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
retinal capillary non-perfusion [ Time Frame: 3 months ]
To assess the percentage of subjects in whom one 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.
Change History Complete list of historical versions of study NCT02957760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
  • retinal capillary non-perfusion [ Time Frame: 2 weeks, 2 months and 6 months ]
    Same criteria of retinal non perfusion as for primary end point
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.
Official Title  ICMJE Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Central Retinal Vein Occlusion, Non-Ischemic
Intervention  ICMJE Drug: Hydroxycarbamid
20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).
Other Name: siklos
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957760
Other Study ID Numbers  ICMJE P15-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Study Sponsor  ICMJE Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborators  ICMJE
  • Robert Debré Hospital
  • Institut National de la Transfusion Sanguine
  • Keyrus Biopharma
  • For Drug Consulting
  • ADDMEDICA SASA
Investigators  ICMJE
Principal Investigator: Jean-François Girmens CHNO des Quinze-Vingts
PRS Account Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP