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Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion (CHIC-3)

This study is currently recruiting participants.
Verified February 2013 by Centre Hospitalier Intercommunal Creteil
Sponsor:
Information provided by (Responsible Party):
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT01448018
First received: September 29, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.


Condition Intervention Phase
Central Retinal Vein Occlusion
 Drug: ranibizumab
Procedure: hemodilution
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • Change in visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months


Secondary Outcome Measures:
  • Gain in visual acuity of 2 ETDRS-lines or more [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients who gained 2 lines or more between baseline and the 6-month visit


Estimated Enrollment: 45
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ranibizumab
patients in this arm receive 3 monthly injection of ranibizumab
 Drug: ranibizumab
3 monthly intravitreous injection as soon as possible after the inclusion
Other Name: Lucentis
Active Comparator: Hemodilution
hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
 Procedure: hemodilution
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Active Comparator: ranibizumab and hemodilution
patients receive both treatments
 Drug: ranibizumab
3 monthly intravitreous injection as soon as possible after the inclusion
Other Name: Lucentis
Procedure: hemodilution
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion

Detailed Description:

Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.

Patients are followed monthly during the 6-month study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CRVO confirmed by fluorescein angiography
  • duration from onset of 1 month or less
  • visual acuity of 20/32 or less

Exclusion Criteria:

  • neovascular complication
  • extensive retinal ischemia requiring prompt panretinal photocoagulation
  • hematocrit level lower than 38%
  • previous laser or surgery in the study eye, etc
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448018

Contacts
Contact: Agnès Glacet-Bernard, MD 331-45175222 agnes.glacet@chicreteil.fr

Locations
France
Intercommunal Hospital Recruiting
Creteil, France, 94000
Contact: Agnès Glacet-Bernard, MD     3        
Principal Investigator: Agnès Glacet-Bernard, MD            
Pitie-Salpetriere Hospital Recruiting
Paris, France, 75013
Contact: Christine Fardeau, MD            
Principal Investigator: Christine Fardeau, MD            
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
  More Information

Publications:

Responsible Party: Agnes Glacet-Bernard, Principal Investigator, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT01448018     History of Changes
Other Study ID Numbers: 2009-011403-23
Study First Received: September 29, 2011
Last Updated: February 21, 2013
Health Authority: France: AFSSAPS (French Agency of Sanitary Security of Health Products)

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
 Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013