LX111 gene therapy for neovascular (wet) age-related macular degeneration
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
This will test a single eye injection of LX111 gene therapy in people 50 and older with active wet AMD to see if it is safe and helps maintain or improve vision.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07053358 on ClinicalTrials.gov |
What this trial studies
This early Phase 1 interventional study gives a single unilateral intravitreal injection of LX111 to adults aged 50 and older with active choroidal neovascularization from neovascular AMD. Participants must have had at least two anti-VEGF injections in the prior six months and shown a meaningful response before enrollment. The trial will closely monitor safety outcomes and measures of visual acuity over scheduled follow-up visits. Results will inform whether LX111 can provide durable control of disease activity with acceptable tolerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with active CNV due to neovascular AMD, best-corrected visual acuity between 5 and 63 ETDRS letters, a prior meaningful response to anti-VEGF therapy, and willingness to attend follow-up visits and use effective contraception if fertile.
Not a fit: Patients with CNV or macular edema from other diseases, serious ocular conditions that limit visual improvement (like retinal detachment, uveitis, uncontrolled glaucoma), recent major cardiovascular events, or uncontrolled hypertension are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, LX111 could reduce the need for frequent anti-VEGF injections and provide longer-lasting control of wet AMD, helping preserve vision.
How similar studies have performed: Other intraocular gene therapy programs for wet AMD (for example AAV-based approaches) have shown early promise in Phase 1/2 studies but remain experimental and not yet established as standard care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.