check_circleStudy Completed
Macular degeneration
Bayer Identifier:
19694
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
AllAge
NaN - N/ATrial summary
Enrollment Goal
1000Trial Dates
May 2018 - November 2018Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many 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 baselinedate_rangeTime Frame:At baseline and 12 months
Secondary Outcome
- Mean time from diagnosis by the treating physician to start of treatmentdate_rangeTime Frame:At baseline
- Proportion of patients gaining 5, 10 or 15 or more lettersdate_rangeTime Frame:At 12 months
- Proportion of patients with ≥70 letters VAdate_rangeTime Frame:At 12 months
- Proportion of patients with ≥73 letters VAdate_rangeTime Frame:At 12 months
- Proportion of patients losing 5, 10 or 15 or more lettersdate_rangeTime Frame:At 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A