ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01448018
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

Brief Summary:
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 or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: ranibizumab Procedure: hemodilution Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in visual acuity [ Time Frame: 6 months ]
    Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months


Secondary Outcome Measures :
  1. Gain in visual acuity of 2 ETDRS-lines or more [ Time Frame: 6 months ]
    Number of patients who gained 2 lines or more between baseline and the 6-month visit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01448018


Locations
France
Intercommunal Hospital
Creteil, France, 94000
Pitie-Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil

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
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents