Belvedere ML43000 (Neovascular Age-Related Macular Degeneration) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to monitor the health of the cornea in participants with neovascular age-related macular degeneration (nAMD), also know as wet AMD, who receive an eye implant that continuously delivers the drug ranibizumab into the back of the eye.
¿Cuál es la Condición que se está estudiando?
Neovascular Age-Related Macular Degeneration (nAMD) AKA "Wet AMD"
¿Quién puede participar en el Estudio?
Adults ages 50+ who:
- Are diagnosed with nAMD (within 18 months of joining study)
- Have not received treatment with intravitreal corticosteroids
- Have not had an intraocular surgery (including cataract surgery) within 6 months of joining the study
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
Si decide participar en el estudio, podrá:
- Get an eye implant, filled with ranibizumab
- Be enrolled in the study for about 1 year
- Visit our clinic at the Duke Eye Center up to 13 times during the study
At various visits, you will have blood tests, eye exams, and vision tests.
Detalles del Estudio
Título Completo
A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients with Neovascular Age-related Macular Degeneration Treated with the Port Delivery System with Ranibizumab (PDS) – Belvedere ML43000
Investigador Principal
Lejla Vajzovic, MD
Especialista en oftalmología
Número de Protocolo
IRB:
PRO00115213
NCT:
NCT04853251
Fase
Phase
IV
ClinicalTrials.gov
Ver en ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción