check_circleStudy Completed

Macular Edema

Bayer Identifier:

17544

ClinicalTrials.gov Identifier:

NCT02425501

EudraCT Number:

Not Available

EU CT Number:

Not Available
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

Trial purpose

The objectives of this study are to investigate the safety and effectiveness of EYLEA

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

  • - Patients who have already received EYLEA treatment

Trial summary

Enrollment Goal
646
Trial Dates
January 2015 - August 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Number of participants of Adverse Events
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants of Serious Adverse Events
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Mean change in visual acuity from baseline to 12 months
    date_rangeTime Frame:
    Baseline to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in retina thickness from baseline to 12 months
    date_rangeTime Frame:
    Baseline to 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
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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