Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Central Retinal Vein Occlusion Clinical Trial

— CHIC-3  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448018
• Other study ID #: 2009-011403-23
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2011
• Last updated: August 12, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS (French Agency of Sanitary Security of Health Products)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
France	Intercommunal Hospital	Creteil
France	Pitie-Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (1)

Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faÿsse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity	Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months	6 months	Yes
Secondary	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	6 months	No