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.

Completed

• Conditions: Wet Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02540369
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Study Start: 2015-12-14
• Primary Completion: 2017-09-25
• Study Completion: 2018-01-26
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2150

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-5321 - with DME	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients
BAY86-5321- with wAMD	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients

Primary Outcome Measures

Name	Time	Method
Mean change of visual acuity.	Baseline and 12 months	Treatment in naïve and previously treated patients for wAMD and DME.

Secondary Outcome Measures

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