check_circleStudy Completed

Macular degeneration

Bayer Identifier:

19694

ClinicalTrials.gov Identifier:

NCT03521895

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • 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

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

Additional Information

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