EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: Special Drug Use Investigation of EYLEA for AMD
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEANumber 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
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 EYLEAMean changes in visual acuity 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) Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments Number and intervals of ITV injection of EYLEA
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who received EYLEA for AMD
Exclusion Criteria:
- Patients who have already received EYLEA
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Japan; Recruiting
Additional Information
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Starting date: December 2012
Last updated: August 7, 2015
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