Actively Recruiting
Safety and Efficacy Evaluation of LX103 Injection in Males With X-Linked Retinoschisis
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2023-04-18
12
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
I
Innostellar Biotherapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the safety and efficacy of LX103 treatment for X-linked retinoschisis (XLRS), a genetic eye condition affecting males aged 6 years and older with documented RS1 gene mutations. The study aims to evaluate how well a single intravitreal injection of LX103 works and monitor for any adverse effects in this group. Participants will receive a single unilateral intravitreal injection of LX103 at the start of the study. Two dose options are being studied: a low dose of 5E10 vector genomes in 0.1 mL per eye and a high dose of 1E11 vector genomes in 0.05 mL per eye. This open-label dose escalation study does not include a placebo group. During the 24-week primary study period, researchers will monitor the incidence of adverse events and serious adverse events. Secondary measurements include changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and electroretinogram (ERG) parameters at 24 and 52 weeks. Participants will attend follow-up visits to assess these outcomes and overall eye health.
CONDITIONS
Brief Title
Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male individuals aged 6 years or older
- Diagnosed with X-linked retinoschisis (XLRS) with documented mutations in the RS1 gene
- Willing to sign informed consent and attend follow-up visits
- Study eye has best-corrected E-ETDRS visual acuity letter score of 63 or less
You will not qualify if you...
- Presence of eye disease interfering with fundus examinations
- Study eye currently receiving or having received topical carbonic anhydrase inhibitors within the past three months
- Study eye underwent intraocular surgery within six months prior to enrollment
- Uncontrolled hypertension or diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants receive a single unilateral intravitreal injection of LX103 at Day 0.
1 treatment visit (in-person)
Duration - Up to 52 weeks
Participants are monitored for safety and efficacy through follow-up visits after treatment.
Multiple follow-up visits over 52 weeks
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, China, 200080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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