Skip to main content
OpenTrials
Completed

NCT Number: NCT01448018

Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intercommunal Hospital, Créteil, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

3 monthly intravitreous injection as soon as possible after the inclusion

Other names: Lucentis

Hemodilution

Procedure

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

Primary outcomes

  1. Change in visual acuity

    Time frame: 6 months

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

Secondary outcomes

  1. Gain in visual acuity of 2 ETDRS-lines or more

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: CHIC-3

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2011
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.