Overview

This trial is active, not recruiting.

Condition retinal vein occlusion
Treatment aflibercept (eylea, vegf trap-eye, bay86-5321)
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date January 2014
End date May 2018
Trial size 300 participants
Trial identifier NCT02040220, 16641, EYL-CRVO

Summary

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 )

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Eylea treatment goup
aflibercept (eylea, vegf trap-eye, bay86-5321)
2 mg of Eylea will be treated per one injection at more than one months interval usually.

Primary Outcomes

Measure
Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)
time frame: 6 months after start of treatment with the drug

Secondary Outcomes

Measure
Effectiveness (visual acuity)
time frame: 6months after start of treatment with the drug
Effectiveness (retina thickness)
time frame: 6months after start of treatment with the drug

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Special Drug Use Investigation of EYLEA for CRVO
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.