Back to resultsHemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion (CHIC-3)
Primary Purpose
Central Retinal Vein Occlusion
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ranibizumab
hemodilution
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion
Eligibility 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
Sites / Locations
- Intercommunal Hospital
- Pitie-Salpetriere Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ranibizumab
Hemodilution
ranibizumab and hemodilution
Arm Description
patients in this arm receive 3 monthly injection of ranibizumab
hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
patients receive both treatments
Outcomes
Primary Outcome Measures
Change in visual acuity
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
Number of patients who gained 2 lines or more between baseline and the 6-month visit
Full Information
NCT ID
NCT01448018
First Posted
September 29, 2011
Last Updated
August 12, 2014
Sponsor
Centre Hospitalier Intercommunal Creteil
1. Study Identification
Unique Protocol Identification Number
NCT01448018
Brief Title
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
Acronym
CHIC-3
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ranibizumab
Arm Type
Active Comparator
Arm Description
patients in this arm receive 3 monthly injection of ranibizumab
Arm Title
Hemodilution
Arm Type
Active Comparator
Arm Description
hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
Arm Title
ranibizumab and hemodilution
Arm Type
Active Comparator
Arm Description
patients receive both treatments
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
3 monthly intravitreous injection as soon as possible after the inclusion
Intervention Type
Procedure
Intervention Name(s)
hemodilution
Intervention Description
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Primary Outcome Measure Information:
Title
Change in visual acuity
Description
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gain in visual acuity of 2 ETDRS-lines or more
Description
Number of patients who gained 2 lines or more between baseline and the 6-month visit
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Intercommunal Hospital
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Pitie-Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20953877
Citation
Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse 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.
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Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
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