NCT02260687

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
353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration 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

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

October 6, 2014

Last Update Submit

September 18, 2019

Conditions

Choroidal Neovascularization

Keywords

AfliberceptAnti-VEGF

Outcome Measures

Primary Outcomes (4)

  • Number of episodes of Adverse drug reaction (ADR's)

    Up to 12 months

  • Number of episodes of Infections

    Up to 12 months

  • Number of episodes of Serious Adverse Events(SAE's)

    Up to 12 months

  • Number of episodes of Ocular Adverse events

    Up to 12 months

Secondary Outcomes (2)

  • Mean changes in visual acuity

    Baseline up to 12 months

  • Mean changes in retina thickness

    Baseline up to 12 months

Study Arms (1)

Group 1

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

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

Interventions

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

Administration by intravitreal injection

Group 1

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 mCNV(myopic choroidal neovascularization) 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 mCNV(myopic choroidal neovascularization).

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 Links

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

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

October 6, 2014

First Posted

October 9, 2014

Study Start

December 5, 2014

Primary Completion

April 2, 2018

Study Completion

August 22, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

JP(1)