Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EYL-AMD | Other Identifier | company internal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received EYLEA for Age-Related Macular Degeneration (AMD).
The objective of this study is to assess safety and effectiveness of EYLEA using in real clinical practice.
A total of 4,000 patients are to be enrolled and assessed in 3 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Patients treated with EYLEA under practical manner for AMD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA | Up to 3 years | |
| Number of participants with serious adverse events (SAEs) and ocular adverse events(AEs) (especially AEs due to ITV injection procedure) from the first ITV injection of EYLEA | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ADRs, SAEs and ocular AEs ( especially AEs due to ITV injection procedure) in subpopulations of patients background characteristics and status of EYLEA treatments from the first ITV injection of EYLEA | Up to 3 years | |
| Mean changes in visual acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with subfovear choroidal neovascular age-related macular degeneration
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37391547 | Derived | Ozawa Y, Ohgami K, Sasaki K, Hirano K, Sunaya T. Long-term surveillance provides real-world evidences of safety and effectiveness in intravitreal aflibercept treatment for age-related macular degeneration. Sci Rep. 2023 Jun 30;13(1):10597. doi: 10.1038/s41598-023-37584-1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and 6, 24 or 36 months |
| Proportion of patients who maintained visual acuity(corresponding to <15 letters of Early Treatment Diabetic Retinopathy Study(ETDRS) from baseline) and improved visual acuity(corresponding to >0 letter of ETDRS from baseline) | Up to 3 years |
| Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments | Baseline and 6, 24 or 36 months |
| Number and intervals of ITV injection of EYLEA | Up to 3 years |