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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| Erasmus Medical Center | OTHER |
| Radboud University Medical Center |
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The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6.
Objective: to compare the effectiveness and costs of 1.25 mg bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during 6 months.
Study Design: This will be a randomized, controlled, double masked, clinical trial in 296 patients in 7 academic trial centres in The Netherlands.
Study population: patients older than 18 years of age with macular edema secondary to a retinal vein occlusion and a best corrected visual acuity (BCVA) score between 78 and 20 letters in the study eye.
Outcomes: The primary outcome measure will be the change in BCVA in the study eye from baseline to month 6.
Secondary outcomes will be amongst others the proportion of patients with a gain of 15 letters or more and/or a BCVA of 20/40 or more at 6 months and the costs per quality adjusted life-year of the two treatments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Active Comparator | Monthly injections with ranibizumab during 6 months |
|
| Bevacizumab | Active Comparator | Monthly injections with bevacizumab during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 1.25 mg bevacizumab administered by monthly interval for six months (6 injections). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a gain or loss of 15 letters or more | The proportion of patients with a gain or loss of 15 letters or more at 6 months compared to baseline BCVA | 6 months |
| Change in leakage on fluorescein angiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reinier O Schlingemann, PhD, MD | Contact | +31 20 5663682 | r.schlingemann@amc.uva.nl | |
| Monique -- Wezel | Contact | +31 205663616 | m.wezel@amc.uva.nl |
| Name | Affiliation | Role |
|---|---|---|
| Reinier O Schlingemann, MD, PhD | Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center, Dept. Ophthalmology | Recruiting | Amsterdam | 1105 AZ | Netherlands |
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| OTHER |
| UMC Utrecht | OTHER |
| University Medical Center Groningen | OTHER |
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| Ranibizumab | Drug | 0.5mg ranibizumab administered by monthly interval for six months (6 injections). |
|
|
The change in leakage on fluorescein angiography at the 6 month exit visit compared to baseline
| 6 months |
| Change in foveal thickness by optical coherence tomography | The change in foveal thickness (central area thickness) by optical coherence tomography at 6 months compared to baseline | 6 months |
| The number of adverse events | The number of adverse events that occurred in the time frame of 6 months and a classification of the type of adverse events | 6 months |
| Costs per quality adjusted life-year of the two treatments | The costs per quality adjusted life-year of the two treatments, results will be based on the use of standardized health questionnaires (EQ5D or HUI3) | 6 months |
| The proportion of patients with a BCVA of 20/40 or more | The proportion of patients with a BCVA of 20/40 or more at 6 months compared to baseline BCVA | 6 months |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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