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Completed

NCT Number: NCT02040220

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

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 )

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)

    Time frame: 6 months after start of treatment with the drug

Secondary outcomes

  1. Effectiveness (visual acuity)

    Time frame: 6months after start of treatment with the drug

  2. Effectiveness (retina thickness)

    Time frame: 6months after start of treatment with the drug

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Special Drug Use Investigation of EYLEA for CRVO

Acronym: JPMS-CRVO

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2014
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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