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

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ClinicalTrials.gov Identifier: NCT01448018
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

September 29, 2011
October 6, 2011
August 13, 2014
January 2010
June 2013   (Final data collection date for primary outcome measure)
Change in visual acuity [ Time Frame: 6 months ]
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
Same as current
Complete list of historical versions of study NCT01448018 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
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
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Central Retinal Vein Occlusion
  • 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
  • Active Comparator: ranibizumab
    patients in this arm receive 3 monthly injection of ranibizumab
    Intervention: Drug: ranibizumab
  • Active Comparator: Hemodilution
    hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
    Intervention: Procedure: hemodilution
  • Active Comparator: ranibizumab and hemodilution
    patients receive both treatments
    • Drug: ranibizumab
    • Procedure: hemodilution
Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faÿsse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil
Centre Hospitalier Intercommunal Creteil
Not Provided
Not Provided
Centre Hospitalier Intercommunal Creteil
August 2014

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