Macular Degeneration
Conditions
Keywords
Wet age-related macular degeneration(wAMD), Diabetic macular edema(DME)
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.
Interventions
Use of intravitreal aflibercept in routine clinical practice in Latin America
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of visual acuity as measured by ETDRS or Snellen chart | At baseline and 12 months | ETDRS: Early treatment diabetic retinopathy study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in retinal thickness as measured by OCT | At baseline and 12 months | OCT: Optical coherence tomography |
| 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 | Up to 12 months | In the previously treated subpopulation |
| Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication | Up to 12 months | In the previously treated subpopulation |
| Percentage of patients with no fluid determined by OCT | At 12 months | Absence of fluid includes all types of fluid and would be determined by physicians judgment |
| Percentage of patients achieving a Snellen equivalent of 20/40 or better | At 12 months | About 70 ETDRS(Early treatment diabetic retinopathy study) letters |
| Percentage of patients gaining ≥15 ETDRS letter | At 12 months | — |
| Presence/absence of pigment epithelium detachments (PED) | At 12 months | In the wAMD population |
| Mean change in visual acuity as measured by ETDRS or Snellen chart | At baseline and 12 months | Mean change in visual acuity between baseline and 12 months for the overall population (treatment naïve + previously treated patients) by indication, wAMD and DME. |
| Type of adjunctive therapies based on medical records or on interviewing the patient | At 12 months | — |
| Diabetic retinopathy severity (mild, moderate, severe) | At 12 months | In the DME population |
| Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient | At 12 months | — |
| Number of monitoring visits | At 12 months | Visits only for diagnostic purposes, but without injections |
| Number of combined visits | At 12 months | Visits for monitoring and injection |
| Number of visits outside the study center | At 12 months | Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc. |
| 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 | — |
| Number of adjunctive therapies | At 12 months | In the DME population |
Countries
Argentina, Colombia, Costa Rica, Mexico
Outcome results
None listed