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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02040220

Acronym

JPMS-CRVO

Enrollment

385

Registered

2014-01-20

Start date

2014-01-24

Completion date

2018-11-09

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vein Occlusion

Keywords

CRVO, Macular edema, Aflibercept, anti-VEGF

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 )

Interventions

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

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026