Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Central Retinal Vein Occlusion

Intervention / Treatment
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* Drug: ranibizumab
* Procedure: hemodilution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ranibizumab<br>patients in this arm receive 3 monthly injection of ranibizumab | Drug: ranibizumab<br>* 3 monthly intravitreous injection as soon as possible after the inclusion<br>* Other names: Lucentis;|
| Active Comparator: Hemodilution<br>hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%) | Procedure: hemodilution<br>* hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion<br>|
| Active Comparator: ranibizumab and hemodilution<br>patients receive both treatments | Drug: ranibizumab<br>* 3 monthly intravitreous injection as soon as possible after the inclusion<br>* Other names: Lucentis;Procedure: hemodilution<br>* hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity | Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |