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Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01448018
Acronym
CHIC-3
Enrollment
45
Registered
2011-10-06
Start date
2010-01-31
Completion date
2013-12-31
Last updated
2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Retinal Vein Occlusion

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.

Interventions

DRUGranibizumab

3 monthly intravitreous injection as soon as possible after the inclusion

PROCEDUREhemodilution

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

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in visual acuity6 monthsChange in best-corrected visual acuity (ETDRS chart) between baseline and 6 months

Secondary

MeasureTime frameDescription
Gain in visual acuity of 2 ETDRS-lines or more6 monthsNumber of patients who gained 2 lines or more between baseline and the 6-month visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026