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| ID | Type | Description | Link |
|---|---|---|---|
| EYL-CRVO | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.
For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Eylea treatment goup |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | 2 mg of Eylea will be treated per one injection at more than one months interval usually. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular) | 6 months after start of treatment with the drug |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness (visual acuity) | 6months after start of treatment with the drug | |
| Effectiveness (retina thickness) | 6months after start of treatment with the drug |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |