To Describe the Use of Intravitreal Aflibercept and to Describe Follow-up as Well as Treatment Patterns in Patients With Wet Age-related Macular Degeneration (wAMD) or Diabetic Macular Edema (DME) in Routine Clinical Practice in Canada. (PEGASUS)

Bayer

Status: Completed

Conditions: Wet Macular Degeneration

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02540369

17995

Details and patient eligibility

About

To describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc).

Enrollment: 2,150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: >= 18 years of age
• Male or female
• Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
• Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician's routine clinical practice.

Exclusion criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
• Ocular or peri-ocular infection
• Active intraocular inflammation
• Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
• Any concomitant therapy with another agent to treat wet AMD or DME in the study eye.

Trial design

2,150 participants in 2 patient groups

BAY86-5321- with wAMD

Description:

Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients

Treatment:

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

BAY86-5321 - with DME

Description:

Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients

Treatment:

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