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 type | Interventional |
|---|---|
| Ages | 6 Years and up |
| Sex | Men only |
| Enrollment | 12 (estimated) |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | December 13, 2022 |
| Main results expected | August 2024 |
| Study ends | August 2028 |
| Registry record updated | April 18, 2023 |
| Trial ID | NCT05814952 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
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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.
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Functional visual field and navigation testing for moderate-to-profound inherited retinal disease
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Gene therapy for X-linked retinoschisis in children and adolescents
This study is testing a new gene therapy for boys aged 5 to 18 with X-linked retinoschisis to see if it can improve their vision and eye health.
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Gene therapy for X-linked retinoschisis
This study is testing a one-time gene therapy injection for boys and men with X-linked retinoschisis to see if it's safe and how well they can tolerate it over five years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.