Clinical trial
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)
Name
SHGH-LX103
Description
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.
Trial arms
Trial start
2022-12-13
Estimated PCD
2024-08-01
Trial end
2028-08-01
Status
Recruiting
Treatment
LX103 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.
Arms:
LX103 Injection
Size
12
Primary endpoint
Incidence of adverse events (AEs)
24 weeks
Incidence of serious adverse events (SAEs)
24 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}
Updated at
2023-04-18
1 organization
1 product
1 indication
Product
LX103Indication
X-linked retinoschisis