Clinical trial Recruiting at 1 site Interventional Ages 6 and up Men only

Evaluating LX103 treatment for X-linked Retinoschisis

Official title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)

Run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT05814952 · Data updated 2026-11-12

This study tests if a new eye treatment called LX103 can improve vision in boys and men with X-linked Retinoschisis.

Quick facts

Study typeInterventional
Ages6 Years and up
SexMen only
Enrollment12 (estimated)
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedDecember 13, 2022
Main results expectedAugust 2024
Study endsAugust 2028
Registry record updatedApril 18, 2023
Trial IDNCT05814952 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are male individuals aged 6 years and older with a confirmed diagnosis of XLRS and specific mutations in the RS1 gene.

Probably not a fit

Patients with other eye diseases that could interfere with examinations or those who have uncontrolled hypertension or diabetes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of a single unilateral intravitreal injection of LX103 in male patients aged 6 years and older diagnosed with X-linked Retinoschisis (XLRS). Participants will be monitored for their visual acuity and any adverse effects following the treatment. The study focuses on individuals with specific genetic mutations in the RS1 gene and aims to provide insights into the potential benefits of LX103 for improving vision in affected patients.

Why it matters

Potential benefit: If successful, this treatment could improve visual outcomes for patients suffering from X-linked Retinoschisis.

How similar studies have gone: While this approach is novel, similar studies targeting genetic conditions have shown promise in the past.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Exclusion Criteria:

1. Any eye with disease that would interfere with the fundus examinations.
2. The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
3. The study eye has undergone intraocular surgery within six months prior to enrollment.
4. Participant has uncontrolled hypertension or diabetes.

Where it's running

  • Shanghai General Hospital, Shanghai Jiao Tong University
    Shanghai, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.