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NCT02040220: JPMS-CRVO

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

Completed Last updated 10 April 2019
What this trial tests

trial testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) in Retinal Vein Occlusion in 385 participants. Completed in 9 November 2018.

Timeline
24 January 2014
Primary endpoint
1 June 2018
9 November 2018

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment385
Start date24 January 2014
Primary completion1 June 2018
Estimated completion9 November 2018
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Eligibility, any sex, with Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 )

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes.
    Shimura M, Fukumatsu M, Tsujimura J, Hirano K, et al · · 2022 · cited 6× · PMID 35256840 · DOI 10.2147/opth.s344194

Verify or expand the search:

Other trials of Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Trials testing the same drug.

Other recruiting trials for Retinal Vein Occlusion

Currently open trials in the same condition.

Other Bayer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02040220.

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