Tests LX111 gene therapy in adults with wet macular degeneration
Tests LX111 gene therapy given by eye injection in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Early phase 1
Where in China
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT07053358
- Record updated
- 10 March 2026
- Original description
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.Read full original descriptionShow less
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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.
Inclusion: Willing to sign the informed consent, and willing to attend follow-up visits; Age ≥ 50; Diagnosis of active CNV secondary to neovascular AMD; BCVA ETDRS letters between 5 and 63; Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy; 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: CNV or macular edema in the study eye secondary to diseases other than nAMD; Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement; Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months; Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg; Uncontrolled diabetes defined as HbA1c >8.0% within 28 days prior to screening.