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

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).

Study Overview

• Status: Completed
• Conditions: Wet Macular Degeneration
• Intervention / Treatment: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 2150

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BAY86-5321- with wAMD; Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
BAY86-5321 - with DME; Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of visual acuity.	Treatment in naïve and previously treated patients for wAMD and DME.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of visual acuity.	For the overall population	Baseline and 12 months
Change of visual acuity by number of Injections.	In 2 sub groups	Baseline and 12 months
Change in Retinal thickness.		Baseline and 12 months
Treatment patterns used in routine clinical practice setting.	Number of visits and examinations per patient	Up to 12 months
Maximum interval between treatments.		Up to 12 months
Mean time between injections.		Up to 12 months
Number of injections at 12 months.		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
In previously treated subpopulation duration of previous treatments		At Baseline
In previously treated subpopulation type of previous treatments.		At Baseline
In previously treated subpopulation reason to switch to Eylea.	Some of the reasons are recurrence of fluid, new hemorrhage - bleed, decreased vision, lack of compliance, patient request, etc.	At Baseline
Proportion of patients with no fluid determined by Optical coherence tomography (OCT).	Absence of fluid would be determined by physician's judgment in the AMD population.	At 4 months, At 12 months
Numbers of patients require adjunctive therapies.	For Diabetic macular edema patients	Up to 12 months
Type of adjunctive therapies required by patients	For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.	Up to 12 months
Number of participants with adverse events as a measure of safety and tolerability.		Up to 12 months
Presence of pigment epithelial detachment (PED) (Y/N)	For Age-related macular degeneration patients.	Baseline and at 12 months
Diabetic retinopathy severity (mild, moderate, severe).	For Diabetic macular edema patients.	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2015
• Primary Completion (Actual): September 25, 2017
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Diabetic macular edema; Wet Age-related macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 17995