Phase 1/2 Study of SB-007 for Stargardt Disease
This study is testing a new treatment called SB-007, given as a shot under the retina (subretinal injection), for people with Stargardt Disease (STGD1). Stargardt Disease is an inherited eye condition that can cause vision loss. The main goals of this study are to see how safe SB-007 is, how well people tolerate it, and if it shows any early signs of improving vision. You may be able to join if you are between 12 and 65 years old. The study aims to enroll about 57 people and will follow them for 96 weeks after a single treatment. The current recruitment status is unclear.
- Study design
- This is a Phase 1/2 study, meaning it's an early-stage trial. It will include about 57 participants to evaluate the safety and initial effectiveness of SB-007.
- What's involved
- Participants will receive a single subretinal injection of SB-007 and will be followed for 96 weeks after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 96 weeks after receiving the treatment to monitor safety.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
Where it's being run
5 sites across 5 statesWho to contact
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What this trial measures
- Safety Measures96 weeks
Safety and tolerability assessed by incidence and/or clinically significant changes in ocular and non-ocular AEs