Clinical Trials in China / NCT06198413
Active, not recruiting
Phase 1
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
NCT06198413 · tracked via the Priya Life Science China tracker
Condition(s) studied
Neovascular Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
LX102 subretinal injection
LX102 subretinal injection: LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Study summary
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
Eligibility
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
Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
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Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
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Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy
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Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
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Other trials for the same condition
TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration
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A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD
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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 NCT06198413 on ClinicalTrials.gov ↗ ← All trials in China