Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LX111 Injection.
- Who it may be relevant to
- Registry conditions: Neovascular Age-related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Overview
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.
Interventions
- Genetic LX111 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.
Primary outcome measures
- Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment [Time frame: 52 weeks]
- Dose Limiting Toxicity [Time frame: 4 weeks]
Secondary outcome measures (3)
- Mean changes in BCVA from Baseline [Time frame: 12 weeks, 36 weeks, 52 weeks]
- Mean changes in Central Subfield Thickness (CST) from Baseline [Time frame: 12 weeks, 36 weeks, 52 weeks]
- The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment [Time frame: 52 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07053358 · SHGH-LX111