Wet Age-related Macular Degeneration
Conditions
Brief summary
In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.
Interventions
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of wAMD. * Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice. * Treatment-naïve in the study eye (no prior therapy for wAMD). * Patient age ≥50 years of age. * Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Exclusion criteria
* Participation in an investigational program with interventions outside of routine clinical practice. * Patients with contraindications to IVT aflibercept listed in the local marketing authorization. * Planned treatment regimen outside of the local marketing authorization. * Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye. * Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye. * Any other retinal disease which may interfere with the treatment of wAMD.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in BCVA (best corrected visual acuity) | Baseline to 12 months | In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T&E (Treat and Extend Regimen)) by label regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in BCVA by intended treatment regimen | Baseline to 12, 24 and 36 months | — |
| The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline | Baseline at 12, 24 and 36 months | With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters. |
| The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters) | At 12, 24 and 36 months | — |
| The change in BCVA | Baseline to 24 and 36 months | — |
| The number of injections | Baseline to 12, 24 and 36 months | — |
| The distribution of the intervals between injections | Up to 36 months | — |
| The changes in central retinal thickness (CRT) | Baseline to 12, 24 and 36 months | — |
Countries
Argentina, Australia, Belgium, Canada, China, Colombia, Denmark, France, Ireland, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom
Outcome results
None listed