Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

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.

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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.

Conditions

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Central Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ranibizumab

patients in this arm receive 3 monthly injection of ranibizumab

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

3 monthly intravitreous injection as soon as possible after the inclusion

Hemodilution

hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)

Group Type ACTIVE_COMPARATOR

hemodilution

Intervention Type PROCEDURE

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

ranibizumab and hemodilution

patients receive both treatments

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

3 monthly intravitreous injection as soon as possible after the inclusion

hemodilution

Intervention Type PROCEDURE

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

Interventions

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ranibizumab

3 monthly intravitreous injection as soon as possible after the inclusion

Intervention Type DRUG

hemodilution

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

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No