An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)
Colección de datos
Enfermedades Oculares+1
+ Degeneración Macular
+ Enfermedades de la Retina
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 2004
Fecha en la que se inscribió al primer participante.To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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 50 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: * Best corrected visual acuity in the study eye between 20/40 and 20/320. * Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size \[including blood, scar/atrophy \& neovascularization\] of \< 12 total disc areas, of which at least 50% must be active CNV. * Any subretinal hemorrhage must comprise no more than 50% of total lesion size. General Criteria: * Patients of either gender, aged greater than 50 years. * Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. * Written informed consent. Exclusion Criteria: * Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. * Patients who are eligible for PDT with Visudyne * Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
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 20 ubicaciones
Connecticut Retina Consultants, L.L.C.
Bridgeport, United StatesNew England Retina Associates
Hamden, United StatesRetina Health Center
Fort Myers, United States