NCT02425501

Brief Summary

The objectives of this study are to investigate the safety and effectiveness of EYLEA

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
646

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

4.3 years

First QC Date

April 21, 2015

Last Update Submit

January 9, 2023

Conditions

Macular Edema

Keywords

Afliberceptanti-VEGF

Outcome Measures

Primary Outcomes (2)

  • Number of participants of Adverse Events

    Up to 12 months

  • Number of participants of Serious Adverse Events

    Up to 12 months

Secondary Outcomes (2)

  • Mean change in visual acuity from baseline to 12 months

    Baseline to 12 months

  • Mean change in retina thickness from baseline to 12 months

    Baseline to 12 months

Study Arms (1)

Aflibercept (Eylea,BAY86-5321)

Decision of EYLEA treatment is made by attending investigator according to the Japanese Package Insert

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321)DRUG

Administration by intravitreal injection

Aflibercept (Eylea,BAY86-5321)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female and male patients with DME diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.

You may qualify if:

  • Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

You may not qualify if:

  • Patients who have already received EYLEA treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

  • Sugimoto M, Handa C, Hirano K, Sunaya T, Kondo M. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3489-3498. doi: 10.1007/s00417-022-05703-9. Epub 2022 Jun 2.

    PMID: 35652946DERIVED

Related Links

MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

January 20, 2015

Primary Completion

April 26, 2019

Study Completion

August 13, 2019

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

JP(1)