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

Macular Degeneration Clinical Trial

— AQUILA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470103
• Other study ID #: 19518
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: January 15, 2021
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Macular Edema

Intervention

Drug:
• Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America

Locations

Country	Name	City	State
Argentina	Many locations	Multiple Locations
Colombia	Many locations	Multiple Locations
Costa Rica	Many locations	Multiple Locations
Mexico	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Colombia,  Costa Rica,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of visual acuity as measured by ETDRS or Snellen chart	ETDRS: Early treatment diabetic retinopathy study	At baseline and 12 months
Secondary	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
Secondary	Change in retinal thickness as measured by OCT	OCT: Optical coherence tomography	At baseline and 12 months
Secondary	Mean time between injections by indication		Up to 12 months
Secondary	Mean number of injections by indication		At 12 months
Secondary	Duration of previous treatments by indication	In the previously treated subpopulation	Up to 12 months
Secondary	Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication	In the previously treated subpopulation	Up to 12 months
Secondary	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
Secondary	Percentage of patients achieving a Snellen equivalent of 20/40 or better	About 70 ETDRS(Early treatment diabetic retinopathy study) letters	At 12 months
Secondary	Percentage of patients gaining =15 ETDRS letter		At 12 months
Secondary	Presence/absence of pigment epithelium detachments (PED)	In the wAMD population	At 12 months
Secondary	Number of adjunctive therapies	In the DME population	At 12 months
Secondary	Type of adjunctive therapies based on medical records or on interviewing the patient		At 12 months
Secondary	Diabetic retinopathy severity (mild, moderate, severe)	In the DME population	At 12 months
Secondary	Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient		At 12 months
Secondary	Number of monitoring visits	Visits only for diagnostic purposes, but without injections	At 12 months
Secondary	Number of combined visits	Visits for monitoring and injection	At 12 months
Secondary	Number of visits outside the study center	Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.	At 12 months
Secondary	Number of optical coherence tomography (OCT) assessments per patient		At 12 months
Secondary	Number of visual acuity tests		At 12 months
Secondary	Number of fundoscopy examinations		At 12 months