Eylea Post Marketing Surveillance(PMS)

NCT ID: NCT01783925

Last Updated: 2023-11-07

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

3206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-29

Study Completion Date

2018-12-31

Brief Summary

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The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Intervention Type DRUG

Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

Interventions

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

Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients determined to start EYLEA treatment
* Patients who agree and sign informed consent
* Patients who receive EYLEA treatment for the first time
* Patients who meet one of the following

* Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD
* Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO)
* Patients diagnosed as having visual impairment due to diabetic macular edema (DME)
* Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)

Exclusion Criteria

* Patients who have received anti-VEGF therapy within 90 days
* Patients who are contraindicated based on the approved product label

* Ocular or periocular infection
* Active severe intraocular inflammation
* Known hypersensitivity to any ingredient of this drug
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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Many Locations

Multiple Locations, , South Korea

Site Status

Countries

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South Korea

References

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Shimura M, Fukumatsu M, Tsujimura J, Hirano K, Sunaya T; Participating Investigators. Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes. Clin Ophthalmol. 2022 Mar 1;16:579-592. doi: 10.2147/OPTH.S344194. eCollection 2022.

Reference Type RESULT
PMID: 35256840 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/study/16469

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Other Identifiers

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EY1310KR

Identifier Type: OTHER

Identifier Source: secondary_id

16469

Identifier Type: -

Identifier Source: org_study_id

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