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The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX102 Dose 1 | Experimental | Low dose of LX102 |
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| LX102 Dose 2 | Experimental | Mid dose of LX102 |
|
| LX102 Dose 3 | Experimental | High dose of LX102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX102 subretinal injection | Genetic | LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses | 4 weeks |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in BCVA from Baseline | BCVA measured by ETDRS | 12 weeks, 36 weeks 52 weeks |
| Mean change in Central Subfield Thickness (CST) from Baseline | CST measured by spectral domain optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Zhejiang University Eye Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42285094 | Derived | Li T, Feng J, Yang X, Yang S, Chen J, Wu Y, Li X, Ni Z, Liu Y, Song M, Huang P, Zheng K, Wang H, Xu X, Sun J, Wang F, Jia H, Sun X. Subretinal rAAV2-based VEGF-Trap gene therapy for neovascular age-related macular degeneration: Preclinical assessment and phase 1 trial results. Cell Rep Med. 2026 Jun 12:102869. doi: 10.1016/j.xcrm.2026.102869. Online ahead of print. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 12 weeks, 36 weeks 52 weeks |
| Mean time from LX102 administration to anti-VEGF rescue injection for the first time | 52 weeks |
| Percentage of participants requiring anti-VEGF rescue injection | 52 weeks |
| Mean number of anti-VEGF rescue injections | 52 weeks |
| Hangzhou |
| Zhejiang |
| China |
| Shanghai General Hospital | Shanghai | China |