A Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America

Sponsor
Bayer
Study ID
NCT03470103
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.

Key Dates

Start date
Mar 28, 2018
Status verified
Jun 2021
Primary completion
Sep 21, 2020
Completion
Jan 15, 2021

Study Design

Enrollment
643 participants (actual)

Arms

  • Arm: Treatment naïve wAMD
    The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
  • Arm: Treatment naïve DME
    The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
  • Arm: Previously treated wAMD
    The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
  • Arm: Previously treated DME
    The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice

Primary Outcome Measure

Mean change of visual acuity as measured by ETDRS or Snellen chart [ Time Frame: At baseline and 12 months ]

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