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

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Completed

CT.gov ID

NCT01448018

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

22.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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 Names: 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 Names: Lucentis Procedure: hemodilution hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion

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 Names:

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 Names:

Lucentis

Procedure: hemodilution

hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion

Outcome Measures

Primary Outcome Measures

Change in visual acuity [6 months]
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 [6 months]
Number of patients who gained 2 lines or more between baseline and the 6-month visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intercommunal Hospital	Creteil		France	94000
2	Pitie-Salpetriere Hospital	Paris		France	75013

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Agnes Glacet-Bernard, Principal Investigator, Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT01448018

Other Study ID Numbers:

2009-011403-23

First Posted:

Oct 6, 2011

Last Update Posted:

Aug 13, 2014

Last Verified:

Aug 1, 2014

Additional relevant MeSH terms:

Retinal Vein Occlusion

Ranibizumab

Study Results

No Results Posted as of Aug 13, 2014