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Eylea Post Marketing Surveillance(PMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Bayer
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01783925
First received: February 1, 2013
Last updated: August 24, 2016
Last verified: August 2016
  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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • Measurement of fundus lesion by fundoscopy [ Time Frame: 4 months or 8 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3600
Study Start Date: April 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783925

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com

Locations
Korea, Republic of
Recruiting
Many 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 
Study First Received: February 1, 2013
Last Updated: August 24, 2016
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on September 28, 2016