check_circleStudy Completed

Retinal Vein Occlusion

Bayer Identifier:

16641

ClinicalTrials.gov Identifier:

NCT02040220

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective, non-interventional, multi-center post-authorization safety study of Eylea for central retinal vein occlusion (CRVO)

Trial purpose

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.
The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.
For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).
There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who start EYLEA treatment for CRVO
  • - Patients who have already received EYLEA treatment
    - Patients who are contraindicated based on approved label

Trial summary

Enrollment Goal
385
Trial Dates
January 2014 - November 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 Locations, Japan

Primary Outcome

  • Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)
    date_rangeTime Frame:
    6 months after start of treatment with the drug
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Effectiveness (visual acuity)
    date_rangeTime Frame:
    6months after start of treatment with the drug
    enhanced_encryption
    Safety Issue:
    No
  • Effectiveness (retina thickness)
    date_rangeTime Frame:
    6months after start of treatment with the drug
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    Safety Issue:
    No

Trial design

Special Drug Use Investigation of EYLEA for CRVO
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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