EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality o... | NCT01756261

Studies
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan

NCT01756261

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 19, 2018Actual

Enrollment

757Actual

Phase

Not provided

Conditions

Macular Degeneration

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EYL-AMD-QOL	Other Identifier	company internal

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2012Actual

Primary Completion Date

Jul 20, 2016Actual

Completion Date

Feb 27, 2017Actual

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

Dec 20, 2012

First Posted Date

Dec 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2018

Last Update Posted Date

Jun 19, 2018Actual

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

757Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Drug	Patients treated with EYLEA under practical manner for AMD.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA		From baseline to 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA		From baseline to 6 and 12 months
Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been determined to start EYLEA treatment
Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858)
Patients who have agreed with the patient informed consent

Exclusion Criteria:

Patients who have already received EYLEA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with subfoveal choroidal neovascular age-related macular degeneration

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C533178	aflibercept

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided