Trial Condition(s):
Macular degeneration
EYLEA Age-Related Macular Degeneration (AMD) post-marketing surveillance in Japan
Bayer Identifier:
15895
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients who received EYLEA for AMD
Exclusion Criteria
- Patients who have already received EYLEA
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Special drug use investigation of EYLEA for AMD
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEATimeframe: 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 EYLEATimeframe: Up to 3 years
Secondary Outcome
- 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 EYLEATimeframe: Up to 3 years
- Mean changes in visual acuityTimeframe: 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)Timeframe: Up to 3 years
- Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatmentsTimeframe: Baseline and 6, 24 or 36 months
- Number and intervals of ITV injection of EYLEATimeframe: Up to 3 years
Additional Information
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