PEGASUS: A Prospective obsErvational Study in Patients With Wet aGe-related Macular Degeneration or Diabetic Macular Edema to ASsess the Use of Intravitreal Aflibercept in roUtine Clinical practiceS in Canada

Bayer0 sites2,150 target enrollmentDecember 14, 2015

ConditionsWet Macular Degeneration

InterventionsAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

DrugsAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Overview

Phase: Not Applicable
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Conditions: Wet Macular Degeneration
Sponsor: Bayer
Enrollment: 2150
Primary Endpoint: Mean change of visual acuity.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

December 14, 2015

End Date

January 26, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

BAY86-5321- with wAMD

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

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

BAY86-5321 - with DME

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

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

Outcomes

Primary Outcomes

Mean change of visual acuity.

Time Frame: Baseline and 12 months

Treatment in naïve and previously treated patients for wAMD and DME.

Secondary Outcomes

Treatment patterns used in routine clinical practice setting.(Up to 12 months)
Change of visual acuity.(Baseline and 12 months)
Change of visual acuity by number of Injections.(Baseline and 12 months)
Change in Retinal thickness.(Baseline and 12 months)
Maximum interval between treatments.(Up to 12 months)
Time to achieve stability of disease.(Up to 12 months)
Number of injections in a year to achieve stability of disease.(Up to 12 months)
Mean time between injections.(Up to 12 months)
Number of injections at 12 months.(Up to 12 months)
In previously treated subpopulation duration of previous treatments(At Baseline)
Proportion of patients with no fluid determined by Optical coherence tomography (OCT).(At 4 months, At 12 months)
Type of adjunctive therapies required by patients(Up to 12 months)
Number of participants with adverse events as a measure of safety and tolerability.(Up to 12 months)
In previously treated subpopulation type of previous treatments.(At Baseline)
In previously treated subpopulation reason to switch to Eylea.(At Baseline)
Presence of pigment epithelial detachment (PED) (Y/N)(Baseline and at 12 months)
Diabetic retinopathy severity (mild, moderate, severe).(Up to 12 months)
Numbers of patients require adjunctive therapies.(Up to 12 months)