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

Study Summary

This Phase 1/2 study will evaluate the safety, tolerability, and preliminary efficacy of subretinal SB-007 administration to determine dose selection in subjects with Stargardt's Type 1 (STGD1). This is a multicenter study which will enroll approximately 57 subjects, followed up over a 96 week period post treatment after a single administration of SB-007.

Interventions

Study Locations

Facility	City	State	Country
UCHealth Sue Anschutz-Rodgers Eye Center,	Aurora	Colorado	United States
Bascom Palmer Eye Institute	Miami	Florida	United States
Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States
Oregon Health & Science University	Portland	Oregon	United States
Retina Foundation of the Southwest	Dallas	Texas	United States

Official Trial Information

View on ClinicalTrials.gov