Eylea Post Marketing Surveillance(PMS)

Bayer

Status: Completed

Conditions: Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Observational

Funder types: Industry

Identifiers

NCT01783925

16469

EY1310KR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 3,206 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,206 participants in 1 patient group

Group 1

Treatment:

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