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RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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

  • GENETIC SB-007

Study Locations (5)

Colorado

  • UCHealth Sue Anschutz-Rodgers Eye Center, — Aurora

Florida

  • Bascom Palmer Eye Institute — Miami

Massachusetts

  • Massachusetts Eye and Ear Infirmary — Boston

Oregon

  • Oregon Health & Science University — Portland

Texas

  • Retina Foundation of the Southwest — Dallas

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2025-02-11
Est. Completion 2028-12-31
Phase Phase 1

Sponsor

Splice Bio

29 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06942572

The ClinicalTrials.gov registry entry for NCT06942572 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Splice Bio, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Stargardt Disease appearing as the primary indexed condition, and to 1 intervention — of which SB-007 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06942572 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Colorado, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06942572 about?

NCT06942572 is a clinical study titled "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 peri...

What is the current status of trial NCT06942572?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2025-02-11. Estimated completion is 2028-12-31.

What conditions does trial NCT06942572 study?

This clinical trial studies the following conditions: Stargardt Disease, Stargardt Macular Dystrophy, Stargardt Macular Degeneration. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06942572?

The interventions under investigation include: SB-007 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06942572?

This trial is sponsored by Splice Bio, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06942572 being conducted?

This trial has 5 study locations across Colorado, Florida, Massachusetts, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial