Study 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

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.

Trial summary

Enrollment Goal

643

Trial Dates

March 2018 - January 2021

Phase

Phase 4

Could I Receive a placebo

Products

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

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many locations	Many locations, Mexico
Completed	Many locations	Many locations, Argentina
Withdrawn	Many locations	Many locations, Brazil
Completed	Many locations	Many locations, Costa Rica
Completed	Many locations	Many locations, Colombia

Primary Outcome

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