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

Bayer1 site in 1 country1,000 target enrollmentMay 1, 2018

ConditionsMacular Degeneration

InterventionsEylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

DrugsEylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Overview

Phase: Not Applicable
Intervention: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Conditions: Macular Degeneration
Sponsor: Bayer
Enrollment: 1000
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2018

End Date

November 30, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

Not provided

Arms & Interventions

Treatment naïve wAMD

Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW

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

Outcomes

Primary Outcomes

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 Outcomes

Proportion of patients gaining 5, 10 or 15 or more letters(At 12 months)
Proportion of patients with ≥70 letters VA(At 12 months)
Mean time from diagnosis by the treating physician to start of treatment(At baseline)
Proportion of patients with ≥73 letters VA(At 12 months)
Proportion of patients losing 5, 10 or 15 or more letters(At 12 months)