Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
- Sponsor
- Centre Hospitalier Intercommunal Creteil
- Study ID
- NCT01448018
- Phase
- PHASE4
- Status
- Completed
Conditions
- Central Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- ranibizumab — DRUG3 monthly intravitreous injection as soon as possible after the inclusion
- hemodilution — PROCEDUREhemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
Study Details
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.
Key Dates
- First listed
- Oct 6, 2011
- Start date
- Jan 31, 2010
- Status verified
- Aug 2014
- Primary completion
- Jun 30, 2013
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 45 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: ranibizumabpatients in this arm receive 3 monthly injection of ranibizumab
- Active Comparator: Hemodilutionhemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%)
- Active Comparator: ranibizumab and hemodilutionpatients receive both treatments
Primary Outcome Measure
Change in visual acuity [ Time Frame: 6 months ]