Clinical trial

Eylea Post Marketing Surveillance

Name

16469

Description

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

Trial arms

Trial start

2014-04-29

Estimated PCD

2018-12-31

Trial end

2018-12-31

Status

Completed

Treatment

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

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

Arms:

Group 1

Size

3206

Primary endpoint

Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)

4 months

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3206, 'type': 'ACTUAL'}}

Updated at

2023-11-07

1 organization

1 product

1 indication

Organization

Bayer

Product

Aflibercept

Indication

Age-Related Macular Degeneration