FALCONAn Open Label, Single Arm Clinical Study of Intravitreal Injection of Conbercept in Patients With Maculae Edema Secondary to Retinal Vein Occlusion (the FALCON Study)
Conbercept
Enfermedades Cardiovasculares+3
+ Enfermedades Oculares
+ Enfermedades de la Retina
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2012
Fecha en la que se inscribió al primer participante.This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment period (3 months) and a PRN period (6 months). In the fixed treatment period patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients are monthly visited and retreatment will be needed according to the retreatment criteria pre-specified.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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: Ability and willingness to provide signed Informed Consent Form. Age ≥ 18, both male and female。 Ocular Inclusion Criterion (Study Eye): Diagnosis of Foveal center-involved macular edema due to RVO (both CRVO and BRVO) within 6 months. Best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73(Snellen equivalents 20/40). Central retinal thickness by OCT in the study eye ≥ 320 μm. Exclusion Criteria: Brisk afferent pupillary defect. History of any anti-VEGF treatment in the study and/or system within 6 months before enrollment, and/or in the fellow eye within 3 month. History of intraocular and/or peri-ocular corticosteroid use in the study eye within 3 months, and/or history of use steroids systemic (p.o., i.m., i.v.) within 1 month. Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye. Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye. Presence of non-RVO disease, in the opinion of the investigator, might cause macular edema, such as AMD (wet or dry), diabetes retinopathy, uveitis etc. Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline. Patients with substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by equal or more than 3 lines or medicine or surgery treatment are needed in the study eye within 4 months. Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease. Pregnant or nursing women. Patients need to exclude in the opinion of investigator.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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 2 ubicaciones
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, ChinaAbrir Beijing Tongren hospital affiliated to Capital Medical University en Google MapsThe Affiliated Eye Hospital of WMC
Wenzhou, China