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.

Wet Macular Degeneration Clinical Trial

— PEGASUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540369
• Other study ID #: 17995
• Status: Completed
• Start date: December 14, 2015
• Est. completion date: January 26, 2018

Study information

• Verified date: February 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2150
• Est. completion date: January 26, 2018
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Edema
• Wet Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of visual acuity.	Treatment in naïve and previously treated patients for wAMD and DME.	Baseline and 12 months
Secondary	Change of visual acuity.	For the overall population	Baseline and 12 months
Secondary	Change of visual acuity by number of Injections.	In 2 sub groups	Baseline and 12 months
Secondary	Change in Retinal thickness.		Baseline and 12 months
Secondary	Treatment patterns used in routine clinical practice setting.	Number of visits and examinations per patient	Up to 12 months
Secondary	Maximum interval between treatments.		Up to 12 months
Secondary	Mean time between injections.		Up to 12 months
Secondary	Number of injections at 12 months.		Up to 12 months
Secondary	Time to achieve stability of disease.		Up to 12 months
Secondary	Number of injections in a year to achieve stability of disease.		Up to 12 months
Secondary	In previously treated subpopulation duration of previous treatments		At Baseline
Secondary	In previously treated subpopulation type of previous treatments.		At Baseline
Secondary	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
Secondary	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
Secondary	Numbers of patients require adjunctive therapies.	For Diabetic macular edema patients	Up to 12 months
Secondary	Type of adjunctive therapies required by patients	For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.	Up to 12 months
Secondary	Number of participants with adverse events as a measure of safety and tolerability.		Up to 12 months
Secondary	Presence of pigment epithelial detachment (PED) (Y/N)	For Age-related macular degeneration patients.	Baseline and at 12 months
Secondary	Diabetic retinopathy severity (mild, moderate, severe).	For Diabetic macular edema patients.	Up to 12 months

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.