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

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01756248
First received: December 20, 2012
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  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: 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:

Drug Information available for: Aflibercept
U.S. FDA Resources

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: 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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

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 19, 2013
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 May 19, 2013