NCT03470103

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
643

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

February 5, 2018

Last Update Submit

June 24, 2021

Conditions

Macular Degeneration

Keywords

Wet age-related macular degeneration(wAMD)Diabetic macular edema(DME)

Outcome Measures

Primary Outcomes (1)

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

    ETDRS: Early treatment diabetic retinopathy study

    At baseline and 12 months

Secondary Outcomes (20)

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

    At baseline and 12 months

  • Change in retinal thickness as measured by OCT

    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

    Up to 12 months

  • +15 more secondary outcomes

Study Arms (4)

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)

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)

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)

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)

Interventions

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

Use of intravitreal aflibercept in routine clinical practice in Latin America

Previously treated DMEPreviously treated wAMDTreatment naïve DMETreatment naïve wAMD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Many locations

Multiple Locations, Argentina

Location

Many locations

Multiple Locations, Colombia

Location

Many locations

Multiple Locations, Costa Rica

Location

Many locations

Multiple Locations, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 36258240DERIVED

  • 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.

    PMID: 35918743DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 19, 2018

Study Start

March 28, 2018

Primary Completion

September 21, 2020

Study Completion

January 15, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations

CO(1)AR(1)ME(1)