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
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
1 other identifier
observational
2,150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedStudy Start
First participant enrolled
December 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedFebruary 15, 2019
February 1, 2019
1.8 years
August 5, 2015
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change of visual acuity.
Treatment in naïve and previously treated patients for wAMD and DME.
Baseline and 12 months
Secondary Outcomes (18)
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
Treatment patterns used in routine clinical practice setting.
Up to 12 months
Maximum interval between treatments.
Up to 12 months
- +13 more secondary outcomes
Study Arms (2)
BAY86-5321- with wAMD
Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients
BAY86-5321 - with DME
Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients
Interventions
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
Eligibility Criteria
Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Unknown Facility
Multiple Locations, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
September 3, 2015
Study Start
December 14, 2015
Primary Completion
September 25, 2017
Study Completion
January 26, 2018
Last Updated
February 15, 2019
Record last verified: 2019-02