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Tests treatment safety and results for Stargardt Disease
Official title 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)
ClinicalTrials.gov ID: NCT06942572
What this study is testing
What is SB-007?
SB-007 is an investigational medicine, being studied as a potential treatment for stargardt disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- To be eligible for study participation, people must meet the following criteria:
- Provide written consent. people under legal age will also provide informed assent according to guidelines set forth by the same.
- Are male or female adolescents and adults, aged as follows:
- In Part A, people will be ≥18 to ≤65\ years (inclusive)
- In Part B, subject age is planned as ≥12 to ≤65\ years (inclusive) \ people aged \>65 years may be eligible in Parts A and B, following discussion...
You likely can't join if
- people must be excluded from participating in the study if they:
- Have had any intraocular surgery (including cataract surgery) or thermal laser within 90 days of the Screening Visit or planned intraocular surgery...
- Have had any major surgical procedure within 30 days of the Screening Visit or planned or anticipated major surgery during the period of the study.
- Have two pathogenic or likely pathogenic variants in IRD genes (other than ABCA4) or a single pathogenic or likely pathogenic variant in autosomal...
- Have a history of amblyopia in the study eye.
- Are unwilling to stop taking the following products at Screening and throughout the study:
See the full eligibility criteria
- To be eligible for study participation, people must meet the following criteria:
- Provide written consent. people under legal age will also provide informed assent according to guidelines set forth by the same.
- Are male or female adolescents and adults, aged as follows:
- In Part A, people will be ≥18 to ≤65\ years (inclusive)
- In Part B, subject age is planned as ≥12 to ≤65\ years (inclusive) \ people aged \>65 years may be eligible in Parts A and B, following discussion with, and approval by, the Medical Monitor.
- Are able to understand and comply with the study procedures.
- Have a diagnosis of STGD1 caused by bi-allelic pathogenic, or likely pathogenic, variants in the ABCA4 gene confirmed genotypically by an accredited genetic testing laboratory
- Clinical evidence consistent with Stargardt Disease type 1.
- For women of child-bearing potential (WOCBP), have a negative pregnancy test at Screening and, if due to receive active treatment, at Day 0.
- For both WOCBP and male people (or their female partners who are of child-bearing potential), agree to either strict abstinence or, if sexually active, use an acceptable contraception measure for 3 months from Day 0
- Must have clear ocular media and adequate pupillary dilation in the study eye, including no allergy to dilating eyedrops, to permit good quality retinal imaging.
- Fulfil visual acuity criteria based on ETDRS letter chart
- Fulfil baseline lesion size measurement, as measured by the Reading Center
- Evidence of disease progression as determined by the Medical Monitor following consultation with the Investigator.
- people must be excluded from participating in the study if they:
- Have had any intraocular surgery (including cataract surgery) or thermal laser within 90 days of the Screening Visit or planned intraocular surgery (including cataract surgery) or thermal laser during the period of the...
- Have had any major surgical procedure within 30 days of the Screening Visit or planned or anticipated major surgery during the period of the study.
- Have two pathogenic or likely pathogenic variants in IRD genes (other than ABCA4) or a single pathogenic or likely pathogenic variant in autosomal dominant or X-linked IRD genes.
- Have a history of amblyopia in the study eye.
- Are unwilling to stop taking the following products at Screening and throughout the study:
- Supplements containing vitamin A or beta-carotene, liver-based products.
- Prescription oral retinoids. Topical products containing vitamin A or retinoids are not exclusionary.
- Have any ophthalmic history of gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or intravitreal or sub-retinal or supra-choroidal injections.
- Have received any investigational therapy within 90 days of the Screening Visit or 5 half-lives, whichever is longer.
- Have known serious allergies to the fluorescein dye that might be used to measure IOP, ocular dilating drops, topical ocular anesthetic, steroid medication, or components of the SB-007 formulation.
- Have any significant ocular or non-ocular disease/disorder which, in the opinion of the Investigator and with concurrence of the Medical Monitor, may either put the subject at risk because of participation in the study...
- Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami, Florida, United States; Boston, Massachusetts, United States; Portland, Oregon, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.