Status: Recruiting
A Phase 1/2, First-in-Human 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)
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.
Participants needed: 57
Trial details
Phase: Phase 1, Phase 2Age: 12-65Biological sex: AllType: InterventionalSponsor: Splice BioUpdated: Apr 29, 2025Locations: 5
Eligibility criteria
Provide written consent. Subjects under legal age will also provide informed ass... [+11]
Have had any intraocular surgery (including cataract surgery) or thermal laser w... [+10]