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)

June 24, 2021 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
643

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Multiple Locations, Argentina
        • Many locations
  • Colombia
      • Multiple Locations, Colombia
        • Many locations
  • Costa Rica
      • Multiple Locations, Costa Rica
        • Many locations
  • Mexico
      • Multiple Locations, Mexico
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and 12 months
Change in retinal thickness as measured by OCT
Time Frame: At baseline and 12 months
OCT: Optical coherence tomography
At baseline and 12 months
Mean time between injections by indication
Time Frame: Up to 12 months
Up to 12 months
Mean number of injections by indication
Time Frame: At 12 months
At 12 months
Duration of previous treatments by indication
Time Frame: Up to 12 months
In the previously treated subpopulation
Up to 12 months
Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication
Time Frame: Up to 12 months
In the previously treated subpopulation
Up to 12 months
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
At 12 months
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
At 12 months
Percentage of patients gaining ≥15 ETDRS letter
Time Frame: At 12 months
At 12 months
Presence/absence of pigment epithelium detachments (PED)
Time Frame: At 12 months
In the wAMD population
At 12 months
Number of adjunctive therapies
Time Frame: At 12 months
In the DME population
At 12 months
Type of adjunctive therapies based on medical records or on interviewing the patient
Time Frame: At 12 months
At 12 months
Diabetic retinopathy severity (mild, moderate, severe)
Time Frame: At 12 months
In the DME population
At 12 months
Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient
Time Frame: At 12 months
At 12 months
Number of monitoring visits
Time Frame: At 12 months
Visits only for diagnostic purposes, but without injections
At 12 months
Number of combined visits
Time Frame: At 12 months
Visits for monitoring and injection
At 12 months
Number of visits outside the study center
Time Frame: At 12 months
Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.
At 12 months
Number of optical coherence tomography (OCT) assessments per patient
Time Frame: At 12 months
At 12 months
Number of visual acuity tests
Time Frame: At 12 months
At 12 months
Number of fundoscopy examinations
Time Frame: At 12 months
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19518 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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