Eylea Post Marketing Surveillance(PMS)

November 3, 2023 updated by: Bayer

Eylea Post Marketing Surveillance

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with wet age-related macular degeneration(wAMD), RVO, DME, and mCNV who are decided to receive EYLEA (VEGF Trap Eye) treatment

Description

Inclusion Criteria:

  • Patients determined to start EYLEA treatment
  • Patients who agree and sign informed consent
  • Patients who receive EYLEA treatment for the first time

  • Patients who meet one of the following

    • Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD
    • Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
    • Patients diagnosed as having visual impairment due to diabetic macular edema (DME)
    • Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)

Exclusion Criteria:

  • Patients who have received anti-VEGF therapy within 90 days

  • Patients who are contraindicated based on the approved product label

    • Ocular or periocular infection
    • Active severe intraocular inflammation
    • Known hypersensitivity to any ingredient of this drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]
Time Frame: 4 months or 8 months
4 months or 8 months
Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
Time Frame: 4 months or 8 months
4 months or 8 months
Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
Time Frame: 4 months or 8 months
4 months or 8 months
IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
Time Frame: 4 months or 8 months
4 months or 8 months
Measurement of fundus lesion by fundoscopy
Time Frame: 4 months or 8 months
4 months or 8 months
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimated)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16469
  • EY1310KR (Other Identifier: company internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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