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

Sponsor
Bayer
Study ID
NCT02040220
Status
Completed

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Jan 24, 2014
Status verified
Apr 2019
Primary completion
Jun 1, 2018
Completion
Nov 9, 2018

Study Design

Enrollment
385 participants (actual)

Arms

  • Arm: Group 1
    Eylea treatment goup

Primary Outcome 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 ]

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