NCT01448018

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Centre Hospitalier Intercommunal Creteil · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	ranibizumab	3 monthly intravitreous injection as soon as possible after the inclusion
PROCEDURE	hemodilution	hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2011-10-06
• Last updated: 2014-08-13

Locations

2 sites across 1 country: France