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
- Conditions
- Macular Degeneration
- Interventions
- Registration Number
- NCT03470103
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 643
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Previously treated DME Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Treatment naïve wAMD Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Treatment naïve DME Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice Previously treated wAMD Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
- Primary Outcome Measures
Name Time Method Mean change of visual acuity as measured by ETDRS or Snellen chart At baseline and 12 months ETDRS: Early treatment diabetic retinopathy study
- Secondary Outcome Measures
Name Time Method Percentage of patients gaining ≥15 ETDRS letter 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
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
Presence/absence of pigment epithelium detachments (PED) At 12 months In the wAMD population
Mean time between injections by indication Up to 12 months Mean number of injections by indication At 12 months 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.
Change in retinal thickness as measured by OCT At baseline and 12 months OCT: Optical coherence tomography
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
Number of optical coherence tomography (OCT) assessments per patient At 12 months Number of visual acuity tests At 12 months Percentage of patients achieving a Snellen equivalent of 20/40 or better At 12 months About 70 ETDRS(Early treatment diabetic retinopathy study) letters
Number of adjunctive therapies At 12 months In the DME population
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 fundoscopy examinations At 12 months Number of visits outside the study center At 12 months Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.
Trial Locations
- Locations (1)
Many locations
🇲🇽Multiple Locations, Mexico
Many locations🇲🇽Multiple Locations, Mexico