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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Active Comparator | patients in this arm receive 3 monthly injection of ranibizumab |
|
| Hemodilution | Active Comparator | hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%) |
|
| ranibizumab and hemodilution | Active Comparator | patients receive both treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 3 monthly intravitreous injection as soon as possible after the inclusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual acuity | Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intercommunal Hospital | Créteil | 94000 | France | |||
| Pitie-Salpetriere Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20953877 | Background | Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse 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. |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D006438 | Hemodilution |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| hemodilution | Procedure | hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion |
|
| Paris |
| 75013 |
| France |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |