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Completed

NCT Number: NCT03470103

A Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America

The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations, Multiple Locations, Argentina

Loading trial locations.

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 for DME patients,
  • Age: ≥55 for wAMD patients
  • Decision to treat with intravitreal aflibercept in the study eye prior to patient enrolment as per the physician's routine clinical practice and following the local Product monograph recommendations. Patients who are treatment naïve (no previous intravitreal treatment received, including, anti- VEGF agents, steroids, steroid implants and/or PDT) and patients that are switching from a different anti-VEGF therapy are both eligible to be included. DME patients that have received previous laser only will be classified as treatment naïve.
  • If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept

Exclusion criteria

  • Patients participating in an investigational program with interventions outside of routine clinical practice.
  • Patients currently being treated with intravitreal aflibercept in the study eye.
  • Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the local product monograph.
  • Ocular or peri-ocular infection in either eye.
  • Active intraocular inflammation in the study eye.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Patients with advanced glaucoma, visually significant cataracts, or any eye disease likely to require surgery during the study period in the study eye.
  • Concomitant ocular or systemic administration of drugs that could interfere with or potentiate the mechanism of action of intravitreal aflibercept, including anti-VEGF agents.
  • Patients receiving a different anti-VEGF agent other than intravitreal aflibercept for the fellow eye.

Treatment and study plan

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

Drug

Use of intravitreal aflibercept in routine clinical practice in Latin America

Primary outcomes

  1. Mean change of visual acuity as measured by ETDRS or Snellen chart

    Time frame: At baseline and 12 months

    ETDRS: Early treatment diabetic retinopathy study

Secondary outcomes

  1. Mean change in visual acuity as measured by ETDRS or Snellen chart

    Time frame: At baseline and 12 months

    Mean change in visual acuity between baseline and 12 months for the overall population (treatment naïve + previously treated patients) by indication, wAMD and DME.

  2. Change in retinal thickness as measured by OCT

    Time frame: At baseline and 12 months

    OCT: Optical coherence tomography

  3. Mean time between injections by indication

    Time frame: Up to 12 months

  4. Mean number of injections by indication

    Time frame: At 12 months

  5. Duration of previous treatments by indication

    Time frame: Up to 12 months

    In the previously treated subpopulation

  6. Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication

    Time frame: Up to 12 months

    In the previously treated subpopulation

  7. Percentage of patients with no fluid determined by OCT

    Time frame: At 12 months

    Absence of fluid includes all types of fluid and would be determined by physicians judgment

  8. Percentage of patients achieving a Snellen equivalent of 20/40 or better

    Time frame: At 12 months

    About 70 ETDRS(Early treatment diabetic retinopathy study) letters

  9. Percentage of patients gaining ≥15 ETDRS letter

    Time frame: At 12 months

  10. Presence/absence of pigment epithelium detachments (PED)

    Time frame: At 12 months

    In the wAMD population

  11. Number of adjunctive therapies

    Time frame: At 12 months

    In the DME population

  12. Type of adjunctive therapies based on medical records or on interviewing the patient

    Time frame: At 12 months

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

    Time frame: At 12 months

    In the DME population

  14. Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient

    Time frame: At 12 months

  15. Number of monitoring visits

    Time frame: At 12 months

    Visits only for diagnostic purposes, but without injections

  16. Number of combined visits

    Time frame: At 12 months

    Visits for monitoring and injection

  17. Number of visits outside the study center

    Time frame: At 12 months

    Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.

  18. Number of optical coherence tomography (OCT) assessments per patient

    Time frame: At 12 months

  19. Number of visual acuity tests

    Time frame: At 12 months

  20. Number of fundoscopy examinations

    Time frame: At 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Prospective Observational Study in Patients With Wet Age-related Macular Degeneration or Diabetic Macular Edema to Assess the freQuency of Use of Intravitreal Aflibercept in Routine Clinical Practices in Latin America

Acronym: AQUILA

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 19, 2018
Registry last updated
Jun 25, 2021

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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