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| ID | Type | Description | Link |
|---|---|---|---|
| EY1510JP | Other Identifier | Company internal |
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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 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 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 |
|---|---|---|---|
| Aflibercept (Eylea,BAY86-5321) | Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | Drug | Administration by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants of Adverse Events | Up to 12 months | |
| Number of participants of Serious Adverse Events | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity from baseline to 12 months | Baseline to 12 months | |
| Mean change in retina thickness from baseline to 12 months | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with DME 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35652946 | Derived | Sugimoto M, Handa C, Hirano K, Sunaya T, Kondo M. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3489-3498. doi: 10.1007/s00417-022-05703-9. Epub 2022 Jun 2. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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