Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Centre Hospitalier Intercommunal Creteil45 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Central Retinal Vein Occlusion

Interventions

ranibizumabDRUG

3 monthly intravitreous injection as soon as possible after the inclusion

hemodilutionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Intercommunal Hospital

Créteil, France

Pitie-Salpetriere Hospital

Paris, France

Outcomes

Primary Outcomes

Change in visual acuity

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

Time frame: 6 months

Secondary Outcomes

Gain in visual acuity of 2 ETDRS-lines or more

Number of patients who gained 2 lines or more between baseline and the 6-month visit

Time frame: 6 months

Data from ClinicalTrials.gov

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