EYLEA Age-Related Macular Degeneration (AMD) Post-marketing Surveillance in Japan

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01756248
First received: December 20, 2012
Last updated: April 18, 2014
Last verified: April 2014
  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.


Condition Intervention
Macular Degeneration
Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation of EYLEA for AMD

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Mean changes in visual acuity [ Time Frame: Baseline and 6, 24 or 36 months ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments [ Time Frame: Baseline and 6, 24 or 36 months ] [ Designated as safety issue: No ]
  • Number and intervals of ITV injection of EYLEA [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: December 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)
Patients treated with EYLEA under practical manner for AMD.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with subfovear choroidal neovascular age-related macular degeneration

Criteria

Inclusion Criteria:

  • Patients who received EYLEA for AMD

Exclusion Criteria:

  • Patients who have already received EYLEA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756248

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01756248     History of Changes
Other Study ID Numbers: 15895, EYL-AMD
Study First Received: December 20, 2012
Last Updated: April 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
EYLEA
Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014