check_circleStudy Completed

Choroidal Neovascularization

Bayer Identifier:

17416

ClinicalTrials.gov Identifier:

NCT02260687

EudraCT Number:

Not Available

EU CT Number:

Not Available
Special Drug Use Investigation of EYLEA for Myopic choroidal neovascularization

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 mCNV(myopic choroidal neovascularization).
  • - Patients who have already received EYLEA treatment.

Trial summary

Enrollment Goal
353
Trial Dates
December 2014 - August 2018
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 episodes of Adverse drug reaction (ADR's)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of episodes of Infections
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of episodes of Serious Adverse Events(SAE's)
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of episodes of Ocular Adverse events
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Mean changes in visual acuity
    date_rangeTime Frame:
    Baseline up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean changes in retina thickness
    date_rangeTime Frame:
    Baseline up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Special Drug Use Investigation of EYLEA for Myopic choroidal neovascularization
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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