NCT02040220

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

Special Drug Use Investigation of EYLEA for CRVO

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 385 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	2 mg of Eylea will be treated per one injection at more than one months interval usually.

Timeline

• Start date: 2014-01-24
• Primary completion: 2018-06-01
• Completion: 2018-11-09
• First posted: 2014-01-20
• Last updated: 2019-04-10

Locations

1 site across 1 country: Japan