Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)

Completed

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02040220
• Lead Sponsor: Bayer

Brief 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 )

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Study Start: 2014-01-24
• Primary Completion: 2018-06-01
• Study Completion: 2018-11-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• Patients who start EYLEA treatment for CRVO

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Exclusion Criteria

• Patients who have already received EYLEA treatment
• Patients who are contraindicated based on approved label

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Eylea treatment goup

Primary Outcome Measures

Name	Time	Method
Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)	6 months after start of treatment with the drug

Secondary Outcome Measures

Name	Time	Method
Effectiveness (visual acuity)	6months after start of treatment with the drug
Effectiveness (retina thickness)	6months after start of treatment with the drug