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) (NCT06942572)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCHealth Sue Anschutz-Rodgers Eye Center, — Aurora, Colorado
Age range: 12 Years to 65 Years
🧪 Interventions in This Study
- SB-007 (GENETIC)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- UCHealth Sue Anschutz-Rodgers Eye Center, — Aurora, Colorado
- Bascom Palmer Eye Institute — Miami, Florida
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts
- Oregon Health & Science University — Portland, Oregon
- Retina Foundation of the Southwest — Dallas, Texas
📞 Contact the Study Coordinator
Phone: +34 934 02 04 56
Email: clinicaltrials@splice.bio
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stargardt Disease
- An Observational Study in Children and Adults With Stargardt Disease — Dallas, Texas
- Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study — Miami, Florida
- Open-Label Extension: Tolerability and Effects of ALK-001 on Stargardt Disease (TEASE) — Phoenix, Arizona
- A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease — Phoenix, Arizona
- Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease — Bakersfield, California
- Study to Evaluate ACDN-01 in ABCA4-related Stargardt Retinopathy (STELLAR) — San Francisco, California
Explore by condition: All Stargardt Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.