Is NCT06942572 recruiting in Aurora, CO?

Yes, NCT06942572 is currently recruiting participants at its Aurora, CO location. This stargardt disease clinical trial is actively enrolling qualified participants.

How do I join the stargardt disease clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Stargardt Disease Clinical Trial in Aurora, CO

About This Stargardt Disease Study in Aurora

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.

Sponsor: Splice Bio

Who Can Participate

Inclusion Criteria

To be eligible for study participation, subjects must meet the following criteria:

Provide written consent. Subjects 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, subjects will be ≥18 to ≤65\

years (inclusive)

In Part B, subject age is planned as ≥12 to ≤65\

years (inclusive) \*Subjects 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 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 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.

Exclusion Criteria

Subjects 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 study, in the study eye.

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, may influence the results of the study, or affect the subject's ability to participate in the study.

Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06942572) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Stargardt Disease Treatment Options in Aurora, CO

If you're searching for stargardt disease treatment options in Aurora, CO, this clinical trial (NCT06942572) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced stargardt disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all stargardt disease clinical trials near you to find additional studies recruiting in your area.

Stargardt Disease Clinical Trial in Aurora, CO

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