Trial Condition(s):

Wet Macular Degeneration

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 Identifier:

17995

ClinicalTrials.gov Identifier:

NCT02540369

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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 Summary

Enrollment Goal
2150
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Canada

Status
Completed
 

Trial Design