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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT01448018
First received: September 29, 2011
Last updated: August 12, 2014
Last verified: August 2014

September 29, 2011
August 12, 2014
January 2010
June 2013   (final data collection date for primary outcome measure)
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
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 ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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. Epub 2010 Oct 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01448018
2009-011403-23
Yes
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