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)

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: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 643

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of visual acuity as measured by ETDRS or Snellen chart	ETDRS: Early treatment diabetic retinopathy study	At baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in visual acuity as measured by ETDRS or Snellen chart	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	OCT: Optical coherence tomography	At baseline and 12 months
Mean time between injections by indication		Up to 12 months
Mean number of injections by indication		At 12 months
Duration of previous treatments by indication	In the previously treated subpopulation	Up to 12 months
Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication	In the previously treated subpopulation	Up to 12 months
Percentage of patients with no fluid determined by OCT	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	About 70 ETDRS(Early treatment diabetic retinopathy study) letters	At 12 months
Percentage of patients gaining ≥15 ETDRS letter		At 12 months
Presence/absence of pigment epithelium detachments (PED)	In the wAMD population	At 12 months
Number of adjunctive therapies	In the DME population	At 12 months
Type of adjunctive therapies based on medical records or on interviewing the patient		At 12 months
Diabetic retinopathy severity (mild, moderate, severe)	In the DME population	At 12 months
Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient		At 12 months
Number of monitoring visits	Visits only for diagnostic purposes, but without injections	At 12 months
Number of combined visits	Visits for monitoring and injection	At 12 months
Number of visits outside the study center	Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.	At 12 months
Number of optical coherence tomography (OCT) assessments per patient		At 12 months
Number of visual acuity tests		At 12 months
Number of fundoscopy examinations		At 12 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Wu L, Bordon AF, Charles M, Rodriguez FJ, Lee J, Machewitz T, Mueller M, Del Carmen Gay G, Fromow-Guerra J; AQUILA investigators. Intravitreal aflibercept for the treatment of patients with neovascular age-related macular degeneration in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Oct 18;8(1):76. doi: 10.1186/s40942-022-00425-w.
• Rodriguez FJ, Wu L, Bordon AF, Charles M, Lee J, Machewitz T, Mueller M, Gay GDC, Fromow-Guerra J; AQUILA Investigators. Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study. Int J Retina Vitreous. 2022 Aug 2;8(1):52. doi: 10.1186/s40942-022-00396-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2018
• Primary Completion (ACTUAL): September 21, 2020
• Study Completion (ACTUAL): January 15, 2021

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Wet age-related macular degeneration(wAMD); Diabetic macular edema(DME)
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID 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