An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03521895
• Date of registration: 30/04/2018
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies GALAXY
• Scientific title: An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies
• Date of first enrolment: May 1, 2018
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03521895
• Study type: Observational

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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

- Exclusion criteria as listed in the local SPC

- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye

- All patients previously treated with any macular laser or any anti-VEGF intravitreal
injections for the study eye will additionally be excluded for this integrated
analysis

- Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW

- Patient who does not meet the local indication criteria for Eylea treatment.
Contraindications listed in the SmPCs must be taken into account

- Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema
(DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central
serous chorioretinopathy (CSC), angioid streaks

- Patient who has previously been treated with any macular laser (laser and/or
visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye

- Patient taking part in an interventional study at the time of enrolment



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Macular Degeneration

Intervention(s)

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Primary Outcome(s)

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 [Time Frame: At baseline and 12 months]

Secondary Outcome(s)

Mean time from diagnosis by the treating physician to start of treatment [Time Frame: At baseline]

Proportion of patients losing 5, 10 or 15 or more letters [Time Frame: At 12 months]

Proportion of patients gaining 5, 10 or 15 or more letters [Time Frame: At 12 months]

Proportion of patients with =70 letters VA [Time Frame: At 12 months]

Proportion of patients with =73 letters VA [Time Frame: At 12 months]

Secondary ID(s)

19694

Source(s) of Monetary Support

Please refer to primary and secondary sponsors