check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

16469

ClinicalTrials.gov Identifier:

NCT01783925

EudraCT Number:

Not Available

EU CT Number:

Not Available
Eylea Post Marketing Surveillance(PMS)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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)
  • - 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

Trial summary

Enrollment Goal
3206
Trial Dates
April 2014 - December 2018
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Korea, Republic Of

Primary Outcome

  • Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
    date_rangeTime Frame:
    4 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]
    date_rangeTime Frame:
    4 months or 8 months
    enhanced_encryption
    Safety Issue:
    No
  • Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
    date_rangeTime Frame:
    4 months or 8 months
    enhanced_encryption
    Safety Issue:
    No
  • Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
    date_rangeTime Frame:
    4 months or 8 months
    enhanced_encryption
    Safety Issue:
    No
  • IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
    date_rangeTime Frame:
    4 months or 8 months
    enhanced_encryption
    Safety Issue:
    No
  • Measurement of fundus lesion by fundoscopy
    date_rangeTime Frame:
    4 months or 8 months
    enhanced_encryption
    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)
    date_rangeTime Frame:
    8 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Eylea Post Marketing Surveillance
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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