Eylea Post Marketing Surveillance(PMS)

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT01783925
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-01
• Study First Posted: 2013-02-05
• Study Start: 2014-04-29
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3206

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]	4 months or 8 months
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)	8 months
Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]	4 months or 8 months
Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]	4 months or 8 months
IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]	4 months or 8 months
Measurement of fundus lesion by fundoscopy	4 months or 8 months

Trial Locations

Locations (1)

Many Locations; 🇰🇷 Multiple Locations, Korea, Republic of