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

This study is currently recruiting participants.

Verified February 2013 by Centre Hospitalier Intercommunal Creteil

Sponsor:

Information provided by (Responsible Party):

Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT01448018

First received: September 29, 2011

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 29, 2011

Last Updated Date

February 21, 2013

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01448018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Central Retinal Vein Occlusion

Intervention ^ICMJE

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

Study Arm (s)

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

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. Epub 2010 Oct 17.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Agnès Glacet-Bernard, MD

331-45175222

agnes.glacet@chicreteil.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01448018

Other Study ID Numbers ^ICMJE

2009-011403-23

Has Data Monitoring Committee

Yes

Responsible Party

Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

Study Sponsor ^ICMJE

Centre Hospitalier Intercommunal Creteil

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Centre Hospitalier Intercommunal Creteil

Verification Date

February 2013

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

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