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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment naïve wAMD<br>The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)<br>* Use of intravitreal aflibercept in routine clinical practice in Latin America<br>|
| Treatment naïve DME<br>The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)<br>* Use of intravitreal aflibercept in routine clinical practice in Latin America<br>|
| Previously treated wAMD<br>The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)<br>* Use of intravitreal aflibercept in routine clinical practice in Latin America<br>|
| Previously treated DME<br>The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)<br>* Use of intravitreal aflibercept in routine clinical practice in Latin America<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of visual acuity as measured by ETDRS or Snellen chart | ETDRS: Early treatment diabetic retinopathy study | At baseline and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet age-related macular degeneration(wAMD), Diabetic macular edema(DME)