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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: Recruiting Phase 1 study of Stargardt Disease and Stargardt Macular Dystrophy, sponsored by Splice Bio.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety and tolerability assessed by incidence and/or clinically significant changes in ocular and non-ocular AEs
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 |
What NCT06942572 shows while recruiting
NCT06942572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 88-participant average among 16 other Stargardt Disease trials with a reported enrollment target (35% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT06942572's enrollment target sits among peer trials
57 8th of 16 higher than 9 of 16 other Stargardt Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stargardt Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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