BridgeMD
A clinical study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SB-007 in Subjects with Stargardt Disease.
EU CTIS ID: 2024-519535-42-00
What this study is testing
The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of subretinal SB-007 administration to determine dose selection in subjects with Stargardt disease type 1 (STGD1) confirmed genotypically to have bi-allelic ABCA4 gene mutations.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Provide written consent.
- 2. Are male or female subjects ≥18 to ≤65 years (inclusive).
- 3. Are able to understand and comply with the study procedures.
- 4. Have a diagnosis of Stargardt disease type 1 (STGD1).
- 5. Clinical evidence consistent with Stargardt Disease type 1.
- 6. For women of child-bearing potential (WOCBP), have a negative pregnancy test at Screening and, if due to receive active treatment, at Day 0.
You likely can't join if
- 1. 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 study, in the study eye.
- 10. Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.
- 2. 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.
- 3. Have two pathogenic or likely pathogenic variants in inherited retinal dystrophy (IRD) genes (other than ABCA4) or a single pathogenic or likely pathogenic variant in autosomal dominant or X-linked IRD genes.
- 4. Have a history of amblyopia in the study eye.
- 5. Are unwilling to stop taking the following products at Screening and throughout the study: a. Supplements containing vitamin A or beta-carotene, liver-based products. b. Prescription oral retinoids. Topical products containing vitamin A or retinoids are not exclusionary.
See the full eligibility criteria
- 1. Provide written consent.
- 2. Are male or female subjects ≥18 to ≤65 years (inclusive).
- 3. Are able to understand and comply with the study procedures.
- 4. Have a diagnosis of Stargardt disease type 1 (STGD1).
- 5. Clinical evidence consistent with Stargardt Disease type 1.
- 6. For women of child-bearing potential (WOCBP), have a negative pregnancy test at Screening and, if due to receive active treatment, at Day 0.
- 7. For both WOCBP and male subjects (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 4 months from Day 0.
- 8. 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.
- 1. 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 study, in the study eye.
- 10. Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.
- 2. 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.
- 3. Have two pathogenic or likely pathogenic variants in inherited retinal dystrophy (IRD) genes (other than ABCA4) or a single pathogenic or likely pathogenic variant in autosomal dominant or X-linked IRD genes.
- 4. Have a history of amblyopia in the study eye.
- 5. Are unwilling to stop taking the following products at Screening and throughout the study: a. Supplements containing vitamin A or beta-carotene, liver-based products. b. Prescription oral retinoids. Topical products containing vitamin A or retinoids are not exclusionary.
- 6. 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.
- 7. Have received any investigational therapy within 90 days of the Screening Visit or 5 half-lives, whichever is longer.
- 8. Have known serious allergies to the fluorescein dye.
- 9. Have any significant ocular or non-ocular disease/disorder.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. 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 EU CTIS; the study team decides eligibility.