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| ID | Type | Description | Link |
|---|---|---|---|
| EY1414JP | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The objectives of this study are to investigate the safety and effectiveness of EYLEA.
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. 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 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients will be recruited.
For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Decision of treatment is made by attending investigator according to the Japanese Package Insert |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Administration by intravitreal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of Adverse drug reaction (ADR's) | Up to 12 months | |
| Number of episodes of Infections | Up to 12 months | |
| Number of episodes of Serious Adverse Events(SAE's) | Up to 12 months | |
| Number of episodes of Ocular Adverse events | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in visual acuity | Baseline up to 12 months | |
| Mean changes in retina thickness | Baseline up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with mCNV(myopic choroidal neovascularization) diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.
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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 |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |