SHJ002 for Near-sightedness

Recruiting at 13 trial locations

Overseen By Suh-Hang H. Juo, MD, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunhawk Vision Biotech, Inc.

Disqualifiers: Axial length > 26 mm, Anisometropia, Astigmatism > 2.00 D, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, SHJ002, to determine if it can safely and effectively slow down near-sightedness (myopia) in children. The study compares SHJ002 with atropine, a common myopia treatment, by having participants use the drops daily for a year. Children aged 3 to 12, who are already nearsighted and can handle eye drops, may be suitable for the trial. As a Phase 2 trial, this research measures how well SHJ002 works in an initial, smaller group of children, offering participants a chance to contribute to important early findings.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must avoid all disallowed medications and refractive correction. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that SHJ002 is likely to be safe for humans?

Research has shown that SHJ002, a treatment targeting microRNA, is generally safe and well-tolerated. Studies have found that, when used as eye drops at the highest tested dose, it did not cause significant side effects. Most participants in these studies did not report any major problems after using the drops. The progression of SHJ002 into further trials indicates researchers' confidence in its safety thus far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for near-sightedness?

Most treatments for near-sightedness, like glasses, contact lenses, or laser surgery, address the symptoms rather than the underlying cause. SHJ002 is unique because it uses a novel eyedrop formulation that targets the eye's growth process, potentially slowing or stopping the progression of near-sightedness. Researchers are excited because, unlike standard treatments, this approach could offer a non-invasive, easy-to-use option that addresses the root of the condition, providing long-term benefits.

What evidence suggests that SHJ002 might be an effective treatment for near-sightedness?

Research has shown that SHJ002, a new treatment tested in this trial, may help control nearsightedness (myopia). In animal studies, SHJ002 reduced eyeball growth more effectively than 0.1% atropine, a common myopia treatment. This trial will compare SHJ002 with atropine to determine its effectiveness in humans. SHJ002 might slow the progression of myopia by targeting specific parts of the eye. While these early animal results are promising, testing in humans is necessary for confirmation. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness, particularly those whose myopia is worsening (degenerative or progressive). Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have a specific level of myopia.

Inclusion Criteria

Literate or able to orally communicate

Parent or guardian able and willing to provide written informed consent

For female subjects of childbearing potential, a negative urinary test

Exclusion Criteria

Anisometropia

I have had a severe eye infection or inflammation recently.

Intraocular pressure > 21 mm Hg or < 6 mm Hg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SHJ002 or Atropine eyedrops once daily for myopia control

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SHJ002

Trial Overview The study tests the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine in controlling myopia. SHJ002 is designed to target a microRNA related to eye growth.

How Is the Trial Designed?

Group I: SHJ002 Experimental Treatment 1 Intervention

The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.

Group II: Atropine Active Control 1 Intervention

The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.

Who Is Running the Clinical Trial?

Sunhawk Vision Biotech, Inc.

Lead Sponsor

Trials

3

Recruited

280+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06579287

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia ... A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.

2. clinicaltherapeutics.com clinicaltherapeutics.com/article/S0149-2918(24)00238-8/fulltext

Safety and Tolerability of Anti–microRNA-328 Ophthalmic ... Using form deprivation myopia in rabbits and mice, we have shown that topical ocular administration of SHJ002 reduced eyeball elongation,9 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291824002388

Safety and Tolerability of Anti–microRNA-328 Ophthalmic ... Using form deprivation myopia in rabbits and mice, we have shown that topical ocular administration of SHJ002 reduced eyeball elongation,9 which implies anti- ...

4. withpower.com withpower.com/trial/phase-2-myopia-7-2024-5674f

SHJ002 for Near-sightedness · Recruiting Participants for ... Trial Overview The study tests the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine in controlling myopia. SHJ002 is designed ...

5. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2769209

Novel eye drops using anti-sense oligonucleotide for myopia ... Furthermore, SHJ002 eye drops were shown to be more effective than 0.1% atropine in reducing axial length in the animal studies. Toxicology studies were ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39244490/?utm_source=Firefox&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1DGwxLt9c5WAPLFfMbTDjU9Sz1ht6JxrscnKrXOmLVpfSMrk37&fc=20240423222149&ff=20240908144331&v=2.18.0.post9+e462414

Safety and Tolerability of Anti-microRNA-328 Ophthalmic ... SHJ002 ophthalmic solution is generally safe and tolerable, which warrants further investigations in Phase II and III trials. Clinicaltrials: ...

7. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2781794

The clinical applications of anti-microRNA-328 therapy ... - IOVS The candidate oligonucleotide, called SHJ002, was selected based on its anti-sense effect and safety data. SHJ002 was formulated as an ophthalmic solution for ...