NCT05814952 Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
| NCT ID | NCT05814952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | X-linked Retinoschisis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-12-13 |
| Primary Completion | 2024-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2022-12-13 with a primary completion date of 2024-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Frequently Asked Questions
Who can join the NCT05814952 clinical trial?
This trial is open to male participants only, aged 6 Years or older, studying X-linked Retinoschisis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05814952 currently recruiting?
Yes, NCT05814952 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine to inquire about joining.
Where is the NCT05814952 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05814952 clinical trial?
NCT05814952 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 12 participants.