Macular Degeneration
Conditions
Brief summary
The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS. The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.
Interventions
Patients observed with regular and irregular treatment course
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
PERSEUS * Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC) * Documentation of at least one Aflibercept (Eylea) injection * Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW * Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made * Patient who meet the local indication criteria for Eylea treatment * At least one BCVA after the 1st Eylea injection * BCVA at baseline * Patient with no history of retinal disease * Patient not previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye (for fellow eye allowed). * For patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. If both eyes are treated during initial visit, the treated eye with worst Best-Corrected Visual Acuity (BCVA) at M0 will be retained. If the two conditions are similar the study eye is the Right eye by convention * Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
Exclusion criteria
PERSEUS *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline | At baseline and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean time from diagnosis by the treating physician to start of treatment | At baseline |
| Proportion of patients gaining 5, 10 or 15 or more letters | At 12 months |
| Proportion of patients with ≥70 letters VA | At 12 months |
| Proportion of patients with ≥73 letters VA | At 12 months |
| Proportion of patients losing 5, 10 or 15 or more letters | At 12 months |
Countries
Germany
Outcome results
None listed