Central Retinal Vein Occlusion
Conditions
Brief 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.
Interventions
3 monthly intravitreous injection as soon as possible after the inclusion
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity | 6 months | Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gain in visual acuity of 2 ETDRS-lines or more | 6 months | Number of patients who gained 2 lines or more between baseline and the 6-month visit |
Countries
France