Trial Condition(s):
Wet Macular Degeneration
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)
Bayer Identifier:
17995
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Mean change of visual acuity.Treatment in naïve and previously treated patients for wAMD and DME.Timeframe: Baseline and 12 months
Secondary Outcome
- Change of visual acuity.For the overall populationTimeframe: Baseline and 12 months
- Change of visual acuity by number of Injections.In 2 sub groupsTimeframe: Baseline and 12 months
- Change in Retinal thickness.Timeframe: Baseline and 12 months
- Treatment patterns used in routine clinical practice setting.Number of visits and examinations per patientTimeframe: Up to 12 months
- Maximum interval between treatments.Timeframe: Up to 12 months
- Mean time between injections.Timeframe: Up to 12 months
- Number of injections at 12 months.Timeframe: Up to 12 months
- Time to achieve stability of disease.Timeframe: Up to 12 months
- Number of injections in a year to achieve stability of disease.Timeframe: Up to 12 months
- In previously treated subpopulation duration of previous treatmentsTimeframe: At Baseline
- In previously treated subpopulation type of previous treatments.Timeframe: 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.Timeframe: 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.Timeframe: At 4 months, At 12 months
- Numbers of patients require adjunctive therapies.For Diabetic macular edema patientsTimeframe: Up to 12 months
- Type of adjunctive therapies required by patientsFor Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.Timeframe: Up to 12 months
- Number of participants with adverse events as a measure of safety and tolerability.Timeframe: Up to 12 months
- Presence of pigment epithelial detachment (PED) (Y/N)For Age-related macular degeneration patients.Timeframe: Baseline and at 12 months
- Diabetic retinopathy severity (mild, moderate, severe).For Diabetic macular edema patients.Timeframe: Up to 12 months
Additional Information
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