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OpenTrials
Completed

NCT Number: NCT01783925

Eylea Post Marketing Surveillance(PMS)

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

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]

    Time frame: 4 months or 8 months

  3. Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]

    Time frame: 4 months or 8 months

  4. IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]

    Time frame: 4 months or 8 months

  5. Measurement of fundus lesion by fundoscopy

    Time frame: 4 months or 8 months

  6. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Eylea Post Marketing Surveillance

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2013
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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