check_circleStudy Completed

Macular degeneration

Bayer Identifier:

19518

ClinicalTrials.gov Identifier:

NCT03470103

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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


  • - 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.

Trial summary

Enrollment Goal
643
Trial Dates
March 2018 - January 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Mexico
Completed
Many locationsMany locations, Argentina
Withdrawn
Many locationsMany locations, Brazil
Completed
Many locationsMany locations, Costa Rica
Completed
Many locationsMany locations, Colombia

Primary Outcome

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

Secondary Outcome

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

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A