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Tests treatment safety and results for Stargardt Disease Type 1 (STGD1)
Official title An Clinical Study Evaluating the Safety, Tolerability, and efficAcy of HG005 in StaRgardT Disease
ClinicalTrials.gov ID: NCT07063251
What this study is testing
What is HG005?
HG005 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for stargardt disease type 1 (stgd1).
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
- Stargardt disease type 1 (STGD1) is a rare genetic eye condition that causes progressive vision loss, often beginning in childhood or adolescence. It is the most common form of inherited macular degeneration and can lead to legal blindness.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Patient ≥ 6 and ≤17 years at the time of signing informed consent, with clinical diagnosis of Stargardt disease;
- At least one ABCA4 allele on each chromosome;
- Both eyes must have well-defined macular atrophic lesions consistent with the diagnosis of Stargardt macular dystrophy.
- Meet visual acuity criteria based on ETDRS letter chart
- Subject must agree to contraception during the study.
You likely can't join if
- Presence of active intraocular inflammation or uveitis history in either eye;
- Presence of ocular or periocular infection history in either eye within 2 weeks prior to selection;
- History or presence of corneal dystrophy in the study eye;
- History of HIV or hepatitis A, B, or C infection;
- Previous treatment with any gene therapy or cell therapy (e.g., stem cell transplantation);
- Additional intraocular surgery in study eye 3 months prior to baseline visit;
See the full eligibility criteria
- Patient ≥ 6 and ≤17 years at the time of signing informed consent, with clinical diagnosis of Stargardt disease;
- At least one ABCA4 allele on each chromosome;
- Both eyes must have well-defined macular atrophic lesions consistent with the diagnosis of Stargardt macular dystrophy.
- Meet visual acuity criteria based on ETDRS letter chart
- Subject must agree to contraception during the study.
- Acceptable hematology, clinical chemistry, urine laboratory, and protocol required eye examination.
- Presence of active intraocular inflammation or uveitis history in either eye;
- Presence of ocular or periocular infection history in either eye within 2 weeks prior to selection;
- History or presence of corneal dystrophy in the study eye;
- History of HIV or hepatitis A, B, or C infection;
- Previous treatment with any gene therapy or cell therapy (e.g., stem cell transplantation);
- Additional intraocular surgery in study eye 3 months prior to baseline visit;
- Participation in an oral therapeutic STGD clinical trial within 3 months (or within 5 half-lives after last dose) prior to Screening
- Any concomitant treatment that, in the opinion of the investigator, might interfere with the surgical procedure or healing process of the eye
- Any other conditions that would not allow the potential subject to complete follow-up examinations during the study and would, in the opinion of the investigator, make the potential subject unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
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, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. 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.