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

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Bayer

Status

Completed

Conditions

Retinal Vein Occlusion

Treatments

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type

Observational

Funder types

Industry

Identifiers

NCT02040220
EYL-CRVO (Other Identifier)
16641

Details and patient eligibility

About

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 )

Enrollment

385 patients

Sex

All

Volunteers

No Healthy Volunteers

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 design

385 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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