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)

• ClinicalTrials.gov Identifier: NCT03470103
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Last Update Posted: June 25, 2021
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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 Design

• Study Type: Observational
• Actual Enrollment: 643 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: March 28, 2018
• Actual Primary Completion Date: September 21, 2020
• Actual Study Completion Date: January 15, 2021

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Argentina

Many locations

Multiple Locations, Argentina

Colombia

Many locations

Multiple Locations, Colombia

Costa Rica

Many locations

Multiple Locations, Costa Rica

Mexico

Many locations

Multiple Locations, Mexico

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03470103
• Other Study ID Numbers: 19518
• First Posted: March 19, 2018
• Last Update Posted: June 25, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

• 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; Aflibercept; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents