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

August 12, 2014 updated by: Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Intercommunal Hospital
      • Paris, France, 75013
        • Pitie-Salpêtrière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity
Time Frame: 6 months
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gain in visual acuity of 2 ETDRS-lines or more
Time Frame: 6 months
Number of patients who gained 2 lines or more between baseline and the 6-month visit
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (ESTIMATE)

October 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-011403-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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