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 (AQUILA)

Bayer

Status: Completed

Conditions: Macular Degeneration

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03470103

19518

Details and patient eligibility

About

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.

Enrollment: 643 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: ≥18 years of age for DME patients,
• Age: ≥55 for wAMD patients
• Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
• If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept

Exclusion criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Patients currently being treated with intravitreal aflibercept in the study eye.
• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
• Ocular or peri-ocular infection in either eye.
• Active intraocular inflammation in the study eye.
• Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
• Patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye.
• Concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-VEGF agents.
• Patients receiving a different anti-VEGF agent other than intravitreal aflibercept for the fellow eye.

Trial design

643 participants in 4 patient groups

Treatment naïve wAMD

Description:

The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice

Treatment:

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

Treatment naïve DME

Description:

The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice

Treatment:

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

Previously treated wAMD

Description:

The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice

Treatment:

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

Previously treated DME

Description:

The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice

Treatment:

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