check_circleStudy Completed

Macular degeneration

An integrated analysis of the effectiveness of intravitreal (IVT) Aflibercept (Eylea) in routine clinical practice based on two large observational studies

Trial purpose

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 Participants Requirements

Sex

All

Age

NaN - N/A

Trial summary

Enrollment Goal
1000
Trial Dates
May 2018 - November 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    At baseline and 12 months

Secondary Outcome

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

Trial design

An integrated analysis of the effectiveness of intravitreal (IVT) Aflibercept (Eylea) in routine clinical practice based on two large observational studies
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A