Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
CHIC-3
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
1 other identifier
interventional
45
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2010
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 13, 2014
August 1, 2014
3.4 years
September 29, 2011
August 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in visual acuity
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
6 months
Secondary Outcomes (1)
Gain in visual acuity of 2 ETDRS-lines or more
6 months
Study Arms (3)
ranibizumab
ACTIVE COMPARATORpatients in this arm receive 3 monthly injection of ranibizumab
Hemodilution
ACTIVE COMPARATORhemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
ranibizumab and hemodilution
ACTIVE COMPARATORpatients receive both treatments
Interventions
3 monthly intravitreous injection as soon as possible after the inclusion
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Eligibility Criteria
You may qualify if:
- CRVO confirmed by fluorescein angiography
- duration from onset of 1 month or less
- visual acuity of 20/32 or less
You may not qualify if:
- neovascular complication
- extensive retinal ischemia requiring prompt panretinal photocoagulation
- hematocrit level lower than 38%
- previous laser or surgery in the study eye, etc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Intercommunal Hospital
Créteil, 94000, France
Pitie-Salpetriere Hospital
Paris, 75013, France
Related Publications (1)
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.
PMID: 20953877BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 6, 2011
Study Start
January 1, 2010
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
August 13, 2014
Record last verified: 2014-08