check_circleStudy Completed

Wet macular degeneration

Bayer Identifier:

17374

ClinicalTrials.gov Identifier:

NCT02279537

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real Life of Aflibercept In FraNce: oBservatiOnnal study in Wet AMD

Trial purpose

The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
    - Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
    - Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
    - Man or woman aged 18 years or more
    - Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;

  • - 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 does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
    - 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
593
Trial Dates
January 2014 - April 2019
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 Locations, France

Primary Outcome

  • Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
    As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
    date_rangeTime Frame:
    Baseline to 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit
    date_rangeTime Frame:
    Baseline to 2 year, 3 year, 4 year
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)
    date_rangeTime Frame:
    Baseline to 1 year, 2 year, 3 year, 4 year
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit
    date_rangeTime Frame:
    Baseline to 1 year, 2 year, 3 year, 4 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

A retrospective and prospective non-interventional open label study to assess the real life of treatment-naive patients with wet age-related macular degeneration in routine clinical practice in France and starting an Anti VEGF Therapy with Aflibercept
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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