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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 (AQUILA)

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ClinicalTrials.gov Identifier: NCT03470103
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Macular Degeneration Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Study Type : Observational
Estimated Enrollment : 730 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment naïve wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America

Treatment naïve DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America

Previously treated wAMD
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America

Previously treated DME
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients with wAMD or DME treated with intravitreal aflibercept. If both eyes are eligible, data from both eyes will be captured, but only one eye will be considered the study eye and included in the study analyses. The eye included will be at the physician's discretion and only visits related to the study eye will be captured in the electronic Case Report Form (eCRF).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470103


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Argentina
Many locations Recruiting
Multiple Locations, Argentina
Brazil
Many locations Not yet recruiting
Multiple Locations, Brazil
Costa Rica
Many locations Recruiting
Multiple Locations, Costa Rica
Mexico
Many locations Recruiting
Multiple Locations, Mexico
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03470103     History of Changes
Other Study ID Numbers: 19518
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Wet age-related macular degeneration(wAMD)
Diabetic macular edema(DME)

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases