Wet Macular Degeneration
Conditions
Keywords
Diabetic macular edema, Wet Age-related macular degeneration
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).
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of visual acuity. | Baseline and 12 months | Treatment in naïve and previously treated patients for wAMD and DME. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of visual acuity by number of Injections. | Baseline and 12 months | In 2 sub groups |
| 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 | — |
| 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 | — |
| Change of visual acuity. | Baseline and 12 months | For the overall population |
| 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. |
| 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. |
| Numbers of patients require adjunctive therapies. | Up to 12 months | For Diabetic macular edema patients |
| 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 | — |
| 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. |
| In previously treated subpopulation duration of previous treatments | At Baseline | — |
Countries
Canada
Outcome results
None listed