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.

Bayer2,150 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

2,150

Conditions

Wet Macular Degeneration

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)DRUG

Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean change of visual acuity.

Treatment in naïve and previously treated patients for wAMD and DME.

Time frame: Baseline and 12 months

Secondary Outcomes

Change of visual acuity.

For the overall population

Time frame: Baseline and 12 months

Change of visual acuity by number of Injections.

In 2 sub groups

Time frame: Baseline and 12 months

Change in Retinal thickness.

Time frame: Baseline and 12 months

Treatment patterns used in routine clinical practice setting.

Number of visits and examinations per patient

Time frame: Up to 12 months

Maximum interval between treatments.

Time frame: Up to 12 months

Mean time between injections.

Time frame: Up to 12 months

Number of injections at 12 months.

Time frame: Up to 12 months

Time to achieve stability of disease.

Time frame: Up to 12 months

Number of injections in a year to achieve stability of disease.

Time frame: Up to 12 months

In previously treated subpopulation duration of previous treatments

Time frame: At Baseline

In previously treated subpopulation type of previous treatments.

Time frame: 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.

Time frame: 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.

Time frame: At 4 months, At 12 months

Numbers of patients require adjunctive therapies.

For Diabetic macular edema patients

Time frame: Up to 12 months

Type of adjunctive therapies required by patients

For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.

Time frame: Up to 12 months

Number of participants with adverse events as a measure of safety and tolerability.

Time frame: Up to 12 months

Presence of pigment epithelial detachment (PED) (Y/N)

For Age-related macular degeneration patients.

Time frame: Baseline and at 12 months

Diabetic retinopathy severity (mild, moderate, severe).

For Diabetic macular edema patients.

Time frame: Up to 12 months

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.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes