Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Phase 4

Completed

• Conditions: Central Retinal Vein Occlusion
• Interventions: Procedure: hemodilution; Drug: ranibizumab

• Registration Number: NCT01448018
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemodilution	hemodilution	hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
ranibizumab and hemodilution	hemodilution	patients receive both treatments
ranibizumab	ranibizumab	patients in this arm receive 3 monthly injection of ranibizumab
ranibizumab and hemodilution	ranibizumab	patients receive both treatments

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gain in visual acuity of 2 ETDRS-lines or more	6 months	Number of patients who gained 2 lines or more between baseline and the 6-month visit

Trial Locations

Locations (2)

Intercommunal Hospital; 🇫🇷 Creteil, France

Pitie-Salpetriere Hospital; 🇫🇷 Paris, France