Trial Condition(s):

Retinal Vein Occlusion

Prospective, non-interventional, multi-center post-authorization safety study of Eylea for central retinal vein occlusion (CRVO) (JPMS-CRVO)

Bayer Identifier:

16641

ClinicalTrials.gov Identifier:

NCT02040220

EudraCT Number:

Not Available

Study Completed

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 )

Inclusion Criteria
- Patients who start EYLEA treatment for CRVO
Exclusion Criteria
- Patients who have already received EYLEA treatment
 - Patients who are contraindicated based on approved label

Trial Summary

Enrollment Goal
385
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design