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

Sponsor
Bayer
Study ID
NCT03521895
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Jan 2020
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018

Study Design

Enrollment
1,000 participants (actual)

Arms

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

Primary Outcome Measure

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 ]

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