Clinical trial NCT02540369: 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Macular Degeneration
Keywords: Diabetic macular edema
Wet Age-related macular degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-09-03
Enrollment: 2150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


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.

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