check_circleStudy Completed

Wet Macular Degeneration

Bayer Identifier:

17634

ClinicalTrials.gov Identifier:

NCT02289924

EudraCT Number:

Not Available

EU CT Number:

Not Available
Aflibercept (Eylea) in roUtine clinical practice in patientS with wet age-related macular degeneration in Italy

Trial purpose

The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of “naïve” patients

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - “Naïve” patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
  • - Exclusion criteria as listed in the local SPC. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
    - Any concomitant therapy with another agent to treat wet AMD in the study eye.
    - Any prior or concomitant therapy with another drug for wAMD.

Trial summary

Enrollment Goal
912
Trial Dates
January 2015 - July 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, Italy

Primary Outcome

  • Mean change of visual acuity from baseline to 12 months.
    date_rangeTime Frame:
    Baseline to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of visual acuity from baseline to 24 months.
    date_rangeTime Frame:
    Baseline to 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of clinical visits (visits for injections)
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of monitoring visits (visits only for diagnostic purposes, but without injections)
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of combined visits (visits for monitoring and injection)
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of post-injection monitoring visits (visits only for safety checks after injection)
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits outside the study center after 12 and 24 months
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of optical coherence tomography (OCT) assessments per patient
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visual acuity tests
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of fundoscopy examinations
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time between the injections and visits
    date_rangeTime Frame:
    At 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time between the first symptoms and diagnosis
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from indication of the Eylea treatment by the treating physician to treatment
    Time will be defined as difference in days between clinical indication for the treatment and the first injection
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with no fluid
    date_rangeTime Frame:
    At 4,12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in retinal thickness from baseline
    As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)
    date_rangeTime Frame:
    Baseline and at 4,12 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

PERSEUS-IT. A Prospective non-intERventional study to asSEss the effectiveness of Aflibercept (Eylea®) in roUtine clinical practice in patientS with wet age-related macular degeneration in Italy
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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