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Completed

NCT Number: NCT02260687

Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

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

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Key information

Conditions

Choroidal Neovascularization Choroid Diseases Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal 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 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 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 mCNV(myopic choroidal neovascularization).

Exclusion criteria

  • Patients who have already received EYLEA treatment.

Treatment and study plan

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

Drug

Administration by intravitreal injection

Primary outcomes

  1. Number of episodes of Adverse drug reaction (ADR's)

    Time frame: Up to 12 months

  2. Number of episodes of Infections

    Time frame: Up to 12 months

  3. Number of episodes of Serious Adverse Events(SAE's)

    Time frame: Up to 12 months

  4. Number of episodes of Ocular Adverse events

    Time frame: Up to 12 months

Secondary outcomes

  1. Mean changes in visual acuity

    Time frame: Baseline up to 12 months

  2. Mean changes in retina thickness

    Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2014
Registry last updated
Sep 19, 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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