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

Centre Hospitalier Intercommunal Creteil

Status and phase

Completed

Phase 4

Conditions

Central Retinal Vein Occlusion

Treatments

Drug: ranibizumab

Procedure: hemodilution

Study type

Interventional

Funder types

Other

Identifiers

NCT01448018

2009-011403-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

ranibizumab

Active Comparator group

Description:

patients in this arm receive 3 monthly injection of ranibizumab

Treatment:

Drug: ranibizumab

Hemodilution

Active Comparator group

Description:

hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)

Treatment:

Procedure: hemodilution

ranibizumab and hemodilution

Active Comparator group

Description:

patients receive both treatments

Treatment:

Drug: ranibizumab

Procedure: hemodilution