An observational study in Wet Macular Degeneration, sponsored by Bayer. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Bayer · Observational
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).
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 2,150 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.
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Patients with wAMD (wet age-related macular degeneration) and DME (Diabetic macular edema) treated by retina specialist/ophthalmologist in selected Canadian clinical sites
Exclusion Criteria:
Patients with wet Age Related Macular Degeneration (wAMD) both naïve and previously treated patients
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients with Diabetic Macular Edema (DME) both naïve and previously treated patients
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
Mean change of visual acuity.
Treatment in naïve and previously treated patients for wAMD and DME.
Time frame: Baseline and 12 months
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
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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