Actively Recruiting
Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2023-04-18
12
Participants Needed
1
Research Sites
294 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
The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.
CONDITIONS
Official Title
Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the informed consent and attend follow-up visits
- Male individuals aged 6 years or older with a diagnosis of X-linked retinoschisis and documented RS1 gene mutations
- Study eye with best-corrected E-ETDRS visual acuity letter score of 63 or less
You will not qualify if you...
- Any eye disease interfering with fundus examinations
- Study eye currently receiving or received topical carbonic anhydrase inhibitors in the past 3 months
- Intraocular surgery in the study eye within 6 months before enrollment
- Uncontrolled hypertension or diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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