NCT02957760

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

November 4, 2016

Last Update Submit

November 25, 2016

Conditions

Central Retinal Vein Occlusion, Non-Ischemic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • retinal capillary non-perfusion

    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.

    2 weks, 2 months, 3 months and 6 months

Interventions

HydroxycarbamidDRUG

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

Also known as: siklos

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHNO des Quinze-Vingts

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Jean-François Girmens

    CHNO des Quinze-Vingts

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Vinet

CONTACT

+33140021126lvinet@15-20.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 8, 2016

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

FR(1)