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OpenTrials
Completed

NCT Number: NCT02540369

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.

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).

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Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Drug

Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.

Primary outcomes

  1. Mean change of visual acuity.

    Time frame: Baseline and 12 months

    Treatment in naïve and previously treated patients for wAMD and DME.

Secondary outcomes

  1. Change of visual acuity.

    Time frame: Baseline and 12 months

    For the overall population

  2. Change of visual acuity by number of Injections.

    Time frame: Baseline and 12 months

    In 2 sub groups

  3. Change in Retinal thickness.

    Time frame: Baseline and 12 months

  4. Treatment patterns used in routine clinical practice setting.

    Time frame: Up to 12 months

    Number of visits and examinations per patient

  5. Maximum interval between treatments.

    Time frame: Up to 12 months

  6. Mean time between injections.

    Time frame: Up to 12 months

  7. Number of injections at 12 months.

    Time frame: Up to 12 months

  8. Time to achieve stability of disease.

    Time frame: Up to 12 months

  9. Number of injections in a year to achieve stability of disease.

    Time frame: Up to 12 months

  10. In previously treated subpopulation duration of previous treatments

    Time frame: At Baseline

  11. In previously treated subpopulation type of previous treatments.

    Time frame: At Baseline

  12. In previously treated subpopulation reason to switch to Eylea.

    Time frame: At Baseline

    Some of the reasons are recurrence of fluid, new hemorrhage - bleed, decreased vision, lack of compliance, patient request, etc.

  13. Proportion of patients with no fluid determined by Optical coherence tomography (OCT).

    Time frame: At 4 months, At 12 months

    Absence of fluid would be determined by physician's judgment in the AMD population.

  14. Numbers of patients require adjunctive therapies.

    Time frame: Up to 12 months

    For Diabetic macular edema patients

  15. Type of adjunctive therapies required by patients

    Time frame: Up to 12 months

    For Diabetic macular edema patients adjunctive therapies as focal laser, steroids, etc.

  16. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: Up to 12 months

  17. Presence of pigment epithelial detachment (PED) (Y/N)

    Time frame: Baseline and at 12 months

    For Age-related macular degeneration patients.

  18. Diabetic retinopathy severity (mild, moderate, severe).

    Time frame: Up to 12 months

    For Diabetic macular edema patients.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: PEGASUS

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 3, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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