AURIGAAn Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting
Colección de datos
Recopilados desde hoy en adelante - ProspectivoAngiopatías Diabéticas+12
+ Retinopatía Diabética
+ Enfermedades Cardiovasculares
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 24 de noviembre de 2017
Fecha en la que se inscribió al primer participante.AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO). The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries. Additionally, utilization and treatment regimens in routine clinical practice will be described. Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 2481 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * For DME \-- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to DME * For macular edema secondary to RVO \-- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to macular edema secondary to RVO * Patient for whom the decision to initiate treatment with aflibercept is made prior to and independent from study participation * Signed informed consent. Exclusion Criteria: * Any contraindications as listed in the local intravitreal aflibercept SmPC (summary of product characteristics) * Current participation in any other clinical (interventional) study or in any other anti-VEGF study * Receipt of systemic anti-VEGF and pro-VEGF treatment * Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study * Patients with prior retinal surgery * Any prior treatment with aflibercept * History of stroke or transient ischemic attacks within the last 6 months * Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 * For patients with prior treatment (i.e. patients that previously have been treated with intravitreal anti-VEGF or steroids): * Previous treatment of the study eye with anti-angiogenic drugs or laser within the last 3 months and patients with ocular surgery of the study eye within the last 3 months * Intravitreal dexamethasone or triamcinolone in the study eye within the last 3 months * Fluocinolone implant within the last 3 years * Dexamethasone implant within the last 6 months * For DME \-- Concomitant therapy with any other agent to treat DME in the study eye. * For macular edema secondary to RVO * Patients who have received or who require pan retinal photocoagulation due to neovascularization * Concomitant therapy with any other agent to treat macular edema secondary to RVO in the study eye.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 11 ubicaciones
Many Locations
Multiple Locations, EgyptMany Locations
Multiple Locations, FranceMany Locations
Multiple Locations, Germany