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Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

NCT ID: NCT02260687

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-05

Study Completion Date

2018-08-22

Brief Summary

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

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Detailed Description

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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) .

Conditions

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Choroidal Neovascularization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Decision of treatment is made by attending investigator according to the Japanese Package Insert

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

Intervention Type DRUG

Administration by intravitreal injection

Interventions

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

Administration by intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).

Exclusion Criteria

* Patients who have already received EYLEA treatment.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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EY1414JP

Identifier Type: OTHER

Identifier Source: secondary_id

17416

Identifier Type: -

Identifier Source: org_study_id

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