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NCT Number: NCT05814952

Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)

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.

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Key information

Conditions

X-linked Retinoschisis Eye Diseases Retinal Degeneration Retinal Diseases Retinoschisis

Age range

6 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Location status: Recruiting

Location contact

Junran Sun, MD

CONTACT

[email protected]

+86 13661995933

Xiaodong Sun, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign the informed consent, and willing to attend follow-up visits.
  • Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
  • The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Exclusion criteria

  • Any eye with disease that would interfere with the fundus examinations.
  • The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
  • The study eye has undergone intraocular surgery within six months prior to enrollment.
  • Participant has uncontrolled hypertension or diabetes.

Treatment and study plan

LX103 Injection

Genetic

Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: 24 weeks

    Incidence of adverse events (AEs) within 24 weeks of LX103 intravitreal injection at different doses

  2. Incidence of serious adverse events (SAEs)

    Time frame: 24 weeks

    Incidence of serious adverse events (SAEs) within 24 weeks of LX103 intravitreal injection at different doses

Secondary outcomes

  1. Mean change from baseline in BCVA (LogMAR) in the study eye

    Time frame: 24 weeks, 52 weeks

    ETDRS visual acuity charts will be used to assess BCVA

  2. Mean change from baseline in central subfield thickness (CST) in the study eye

    Time frame: 24 weeks, 52 weeks

    Mean change of CST measured using Optical Coherence Tomography (OCT)

  3. Change from baseline in Electroretinogram (ERG) parameters in the study eye

    Time frame: 24 weeks, 52 weeks

    Change in dark-adapted 3.0 B-wave amplitude (μV)

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Innostellar Biotherapeutics

Registry information

Official study title

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)

Important dates

Study start
2022
Primary completion
2024
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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