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NCT06942572 · ClinicalTrials.gov registry record · 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)
A Phase 1 study of Stargardt Disease and Stargardt Macular Dystrophy, sponsored by Splice Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 5
- Study locations
NCT06942572 is a Phase 1 study of Stargardt Disease and Stargardt Macular Dystrophy that is actively recruiting participants, run by Splice Bio. The registered enrollment target is 57 participants, below the 88-participant average among 16 other Stargardt Disease trials with a reported enrollment target (35% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06942572, a Phase 1 study of Stargardt Disease and Stargardt Macular Dystrophy, is actively recruiting participants, sponsored by Splice Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 5
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2025-02-11 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
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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, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 16 other Stargardt Disease trials with a reported enrollment target (35% lower). The listed sponsor is Splice Bio, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT06942572 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Florida, Massachusetts.
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.
What interventions are being tested in trial NCT06942572?
The interventions under investigation include: SB-007 (GENETIC).
Who is sponsoring clinical trial NCT06942572?
This trial is sponsored by Splice Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.