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Eylea Post Marketing Surveillance(PMS)

This study is currently recruiting participants.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783925
First Posted: February 5, 2013
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
  Purpose
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

Condition Intervention
Macular Degeneration Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eylea Post Marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] [ Time Frame: 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 ]
  • IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] [ Time Frame: 4 months or 8 months ]
  • Measurement of fundus lesion by fundoscopy [ Time Frame: 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 ]

Estimated Enrollment: 3600
Actual Study Start Date: April 29, 2014
Estimated Study Completion Date: March 18, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783925


Contacts
Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com

Locations
Korea, Republic of
Many Locations Recruiting
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01783925     History of Changes
Other Study ID Numbers: 16469
EY1310KR ( Other Identifier: company internal )
First Submitted: February 1, 2013
First Posted: February 5, 2013
Last Update Posted: December 1, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases