The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
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
6. Demonstrated a meaningful response to anti-VEGF therapy
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 \>7.5%
Primary outcome measure(s)
Incidence of dose-limiting toxicity (DLT) — 4 weeks Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
Incidence of adverse events (AEs) and serious adverse events (SAEs) — 52 weeks Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
Trial sites (3)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Zhejiang University Eye Hospital
Hangzhou
Zhejiang
Shanghai General Hospital
Shanghai
China
More Innostellar Biotherapeutics Co.,Ltd trials in China
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.
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