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.

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Wet Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, Wet Age-related macular degeneration