Wet Macular Degeneration
Conditions
Keywords
wet AMD
Brief summary
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of naïve patients
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Naïve patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of visual acuity from baseline to 12 months. | Baseline to 12 months |
| Mean change of visual acuity from baseline to 24 months. | Baseline to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of combined visits (visits for monitoring and injection) | At 12 and 24 months | — |
| Number of post-injection monitoring visits (visits only for safety checks after injection) | At 12 and 24 months | — |
| Number of visits outside the study center after 12 and 24 months | At 12 and 24 months | — |
| Number of optical coherence tomography (OCT) assessments per patient | At 12 and 24 months | — |
| Number of visual acuity tests | At 12 and 24 months | — |
| Number of clinical visits (visits for injections) | At 12 and 24 months | — |
| Mean time between the injections and visits | At 12 and 24 months | — |
| Mean time between the first symptoms and diagnosis | Up to 24 months | — |
| Mean time from indication of the Eylea treatment by the treating physician to treatment | Up to 24 months | Time will be defined as difference in days between clinical indication for the treatment and the first injection |
| Proportion of patients with no fluid | At 4,12 and 24 months | — |
| Mean change in retinal thickness from baseline | Baseline and at 4,12 and 24 months | As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope) |
| Number of fundoscopy examinations | At 12 and 24 months | — |
| Number of monitoring visits (visits only for diagnostic purposes, but without injections) | At 12 and 24 months | — |
Countries
Italy
Outcome results
None listed