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Recruiting Early Phase 1

Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients

NCT07053358 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-07-02
Last updated
2026-03-10

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

LX111 Injection

LX111 Injection: Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.

Study summary

The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits. 2. Age ≥ 50 3. Diagnosis of active CNV secondary to neovascular AMD 4. BCVA ETDRS letters between 5 and 63 5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy 6. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up. Exclusion Criteria: 1. CNV or macular edema in the study eye secondary to diseases other than nAMD 2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement 3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months 4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg 5. Uncontrolled diabetes defined as HbA1c \>8.0% within 28 days prior to screening

Primary outcome measure(s)

  • Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment — 52 weeks
    Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.
  • Dose Limiting Toxicity — 4 weeks
    The incidence of DLT in each dose group.

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07053358 on ClinicalTrials.gov ↗ ← All trials in China