Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY86-5321- with wAMD | Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients |
| |
| BAY86-5321 - with DME | Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of visual acuity. | Treatment in naïve and previously treated patients for wAMD and DME. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of visual acuity. | For the overall population | Baseline and 12 months |
| Change of visual acuity by number of Injections. | In 2 sub groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Canada |
Not provided
Not provided
Not provided
Not provided
| Baseline and 12 months |
| Change in Retinal thickness. | Baseline and 12 months |
| Treatment patterns used in routine clinical practice setting. | Number of visits and examinations per patient | Up to 12 months |
| Maximum interval between treatments. | Up to 12 months |
| Mean time between injections. | Up to 12 months |
| Number of injections at 12 months. | 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 |
| In previously treated subpopulation duration of previous treatments | At Baseline |
| In previously treated subpopulation type of previous treatments. | 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. | 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. | At 4 months, At 12 months |
| Numbers of patients require adjunctive therapies. | For Diabetic macular edema patients | Up to 12 months |
| Type of adjunctive therapies required by patients | For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc. | Up to 12 months |
| Number of participants with adverse events as a measure of safety and tolerability. | Up to 12 months |
| Presence of pigment epithelial detachment (PED) (Y/N) | For Age-related macular degeneration patients. | Baseline and at 12 months |
| Diabetic retinopathy severity (mild, moderate, severe). | For Diabetic macular edema patients. | Up to 12 months |
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided