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

Bayer643 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

643

Conditions

Macular Degeneration

Interventions

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

Use of intravitreal aflibercept in routine clinical practice in Latin America

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes