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

NCT ID: NCT02040220

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-24
• Study Completion Date: 2018-11-09

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 )

Conditions

Retinal Vein Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Eylea treatment goup

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

Intervention Type: DRUG

2 mg of Eylea will be treated per one injection at more than one months interval usually.

Interventions

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

2 mg of Eylea will be treated per one injection at more than one months interval usually.

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Japan

Countries

Japan

Other Identifiers

EYL-CRVO

Identifier Type: OTHER

Identifier Source: secondary_id

16641

Identifier Type: -

Identifier Source: org_study_id