Macular Degeneration
Conditions
Keywords
EYLEA, Age-Related Macular Degeneration
Brief summary
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.
Interventions
DRUGAflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who received EYLEA for AMD
Exclusion criteria
* Patients who have already received EYLEA
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Baseline and 6, 24 or 36 months |
| Number and intervals of ITV injection of EYLEA | 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 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 |
Countries
Japan
Outcome results
None listed