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OpenTrials
Completed

NCT Number: NCT02425501

Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

The objectives of this study are to investigate the safety and effectiveness of EYLEA

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

About this study

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. 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. In total, 600 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

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 Diabetic Macular Edema (DME)

Exclusion criteria

  • Patients who have already received EYLEA treatment

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

Administration by intravitreal injection

Primary outcomes

  1. Number of participants of Adverse Events

    Time frame: Up to 12 months

  2. Number of participants of Serious Adverse Events

    Time frame: Up to 12 months

Secondary outcomes

  1. Mean change in visual acuity from baseline to 12 months

    Time frame: Baseline to 12 months

  2. Mean change in retina thickness from baseline to 12 months

    Time frame: Baseline to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2015
Registry last updated
Jan 11, 2023

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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