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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 EYLEA

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

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 EYLEA

Mean 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

Page last updated: August 23, 2015

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