check_circleStudy Completed

Wet macular degeneration

Bayer Identifier:

17995

ClinicalTrials.gov Identifier:

NCT02540369

EudraCT Number:

Not Available

EU CT Number:

Not Available
To describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wet Age-related macular degeneration (wAMD) or Diabetic macular edema (DME) in routine clinical practice in Canada.

Trial purpose

To describe the use of intravitreal aflibercept in routine clinical practice and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Canada for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Age: >= 18 years of age
    - Male or female
    - Patients with wet AMD (wet age-related macular degeneration) or Diabetic macular edema (DME) who will be treated by intravitreal aflibercept according to the Canadian Product monograph recommendations and routine clinical practice.
    - Decision to treat with intravitreal aflibercept prior to patient enrolment as per the physician’s routine clinical practice.
  • - Patients participating in an investigational program with interventions outside of routine clinical practice.
    - Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept, both naïve and previously treated with other anti-VEGF therapies.
    - Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
    - Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container.
    - Ocular or peri-ocular infection
    - Active intraocular inflammation
    - Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
    - Any concomitant therapy with another agent to treat wet AMD or DME in the study eye.

Trial summary

Enrollment Goal
2150
Trial Dates
December 2015 - January 2018
Phase
N/A
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, Canada

Primary Outcome

  • Mean change of visual acuity.
    Treatment in naïve and previously treated patients for wAMD and DME.
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change of visual acuity.
    For the overall population
    date_rangeTime Frame:
    Baseline and 12 months
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    Safety Issue:
    No
  • Change of visual acuity by number of Injections.
    In 2 sub groups
    date_rangeTime Frame:
    Baseline and 12 months
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    Safety Issue:
    No
  • Change in Retinal thickness.
    date_rangeTime Frame:
    Baseline and 12 months
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    Safety Issue:
    No
  • Treatment patterns used in routine clinical practice setting.
    Number of visits and examinations per patient
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Maximum interval between treatments.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Mean time between injections.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Number of injections at 12 months.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Time to achieve stability of disease.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Number of injections in a year to achieve stability of disease.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • In previously treated subpopulation duration of previous treatments
    date_rangeTime Frame:
    At Baseline
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    Safety Issue:
    No
  • In previously treated subpopulation type of previous treatments.
    date_rangeTime Frame:
    At Baseline
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    Safety Issue:
    No
  • In previously treated subpopulation reason to switch to Eylea.
    Some of the reasons are recurrence of fluid, new hemorrhage – bleed, decreased vision, lack of compliance, patient request, etc.
    date_rangeTime Frame:
    At Baseline
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    Safety Issue:
    No
  • Proportion of patients with no fluid determined by Optical coherence tomography (OCT).
    Absence of fluid would be determined by physician’s judgment in the AMD population.
    date_rangeTime Frame:
    At 4 months, At 12 months
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    Safety Issue:
    No
  • Numbers of patients require adjunctive therapies.
    For Diabetic macular edema patients
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No
  • Type of adjunctive therapies required by patients
    For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability.
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    Yes
  • Presence of pigment epithelial detachment (PED) (Y/N)
    For Age-related macular degeneration patients.
    date_rangeTime Frame:
    Baseline and at 12 months
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    Safety Issue:
    No
  • Diabetic retinopathy severity (mild, moderate, severe).
    For Diabetic macular edema patients.
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

PEGASUS: A Prospective obsErvational study in patients with wet aGe-related macular degeneration or diabetic macular edema to ASsess the use of intravitreal aflibercept in roUtine clinical practiceS in Canada
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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