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| ID | Type | Description | Link |
|---|---|---|---|
| EY1310KR | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity] | 4 months or 8 months | |
| Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] | 4 months or 8 months |
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Inclusion Criteria:
Patients determined to start EYLEA treatment
Patients who agree and sign informed consent
Patients who receive EYLEA treatment for the first time
Patients who meet one of the following
Exclusion Criteria:
Patients who have received anti-VEGF therapy within 90 days
Patients who are contraindicated based on the approved product label
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Patients diagnosed with wet age-related macular degeneration(wAMD), RVO, DME, and mCNV who are decided to receive EYLEA (VEGF Trap Eye) treatment
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35256840 | Result | Shimura M, Fukumatsu M, Tsujimura J, Hirano K, Sunaya T; Participating Investigators. Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes. Clin Ophthalmol. 2022 Mar 1;16:579-592. doi: 10.2147/OPTH.S344194. eCollection 2022. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography] | 4 months or 8 months |
| IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] | 4 months or 8 months |
| Measurement of fundus lesion by fundoscopy | 4 months or 8 months |
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) | 8 months |