Evaluating LX103 treatment for X-linked Retinoschisis
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)
This study tests if a new eye treatment called LX103 can improve vision in boys and men with X-linked Retinoschisis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 6 Years and up |
| Sex | Male |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05814952 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
Why it matters
Potential benefit: If successful, this treatment could improve visual outcomes for patients suffering from X-linked Retinoschisis.
How similar studies have performed: While this approach is novel, similar studies targeting genetic conditions have shown promise in the past.
Eligibility criteria
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 this trial is running
Shanghai
- Shanghai General Hospital, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.