Clinical trial NCT03470103: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Wet age-related macular degeneration(wAMD)
Diabetic macular edema(DME)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Mean change of visual acuity as measured by ETDRS or Snellen chart
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Mean change in visual acuity as measured by ETDRS or Snellen chart
timeFrame: At baseline and 12 months
measure: Change in retinal thickness as measured by OCT
timeFrame: At baseline and 12 months
measure: Mean time between injections by indication
timeFrame: Up to 12 months
measure: Mean number of injections by indication
timeFrame: At 12 months
measure: Duration of previous treatments by indication
timeFrame: Up to 12 months
measure: Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication
timeFrame: Up to 12 months
measure: Percentage of patients with no fluid determined by OCT
timeFrame: At 12 months
measure: Percentage of patients achieving a Snellen equivalent of 20/40 or better
timeFrame: At 12 months
measure: Percentage of patients gaining ≥15 ETDRS letter
timeFrame: At 12 months
measure: Presence/absence of pigment epithelium detachments (PED)
timeFrame: At 12 months
measure: Number of adjunctive therapies
timeFrame: At 12 months
measure: Type of adjunctive therapies based on medical records or on interviewing the patient
timeFrame: At 12 months
measure: Diabetic retinopathy severity (mild, moderate, severe)
timeFrame: At 12 months
measure: Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient
timeFrame: At 12 months
measure: Number of monitoring visits
timeFrame: At 12 months
measure: Number of combined visits
timeFrame: At 12 months
measure: Number of visits outside the study center
timeFrame: At 12 months
measure: Number of optical coherence tomography (OCT) assessments per patient
timeFrame: At 12 months
measure: Number of visual acuity tests
timeFrame: At 12 months
measure: Number of fundoscopy examinations
timeFrame: At 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
facility: Many locations
city: Multiple Locations
country: Colombia
facility: Many locations
city: Multiple Locations
country: Costa Rica
facility: Many locations
city: Multiple Locations
country: Mexico
facility: Many locations
Study officials:
References:
citation: 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.
citation: 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.