ASTRA SB-007 CS-101 (Stargardt Disease Type 1) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find out if an experimental drug called SB-007 (the stud drug) is a safe and effective option for people with STGD1.
¿Cuál es la Condición que se está estudiando?
Stargardt Disease Type 1 (STGD1)
¿Quién puede participar en el Estudio?
Children and adults ages 12-65 who:
- Are diagnosed with STGD1
- Have no history of amblyopia (lazy eye)
For more information, contact the study team at DEC-RA@duke.edu.
Grupo etario
Adultos, Niños
¿Qué Implica?
If you choose to join this study, you will get a single injection of the study drug directly into the eye.
Participation in the study will last for up to 8 years and involve about 11 visits to our clinic. During these visits, you will have eye exams, blood tests, and fill out surveys.
Detalles del Estudio
Título Completo
A Phase 1/2, First-in-Human, Open-label, Assessor-Masked, Randomized, Controlled, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Subretinal Injection of SB-007 in Subjects with Stargardt Disease (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily A Member 4 (ABCA4) Gene (ASTRA) - SB-007 CS-101
Investigador Principal
Ramiro S. Maldonado, MD
Especialista en oftalmología
Número de Protocolo
IRB:
PRO00116715
Fase
Phase I/II
Estado de inscripción
Abierto para inscripción