check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

15895

ClinicalTrials.gov Identifier:

NCT01756248

EudraCT Number:

Not Available

EU CT Number:

Not Available
EYLEA Age-Related Macular Degeneration (AMD) post-marketing surveillance in Japan

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who received EYLEA for AMD

  • - Patients who have already received EYLEA

Trial summary

Enrollment Goal
3872
Trial Dates
December 2012 - May 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Number of participants with adverse drug reactions(ADRs) and infections from the first intravitreal(ITV) injection of EYLEA
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    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
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

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
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Mean changes in visual acuity
    date_rangeTime Frame:
    Baseline and 6, 24 or 36 months
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Mean changes in visual acuity in subpopulations of patients background characteristics and status of EYLEA treatments
    date_rangeTime Frame:
    Baseline and 6, 24 or 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number and intervals of ITV injection of EYLEA
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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