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| Name | Class |
|---|---|
| Tianjin Medical University Eye Hospital | OTHER |
| Eye & ENT Hospital of Fudan University | OTHER |
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Age-related macular degeneration (AMD) is a progressive disease leading to severe and irreversible vision loss of which the neovascular AMD (nAMD) accounted for 90% blindness in AMD. nAMD is primarily driven by the perturbation of vascular endothelial growth factor (VEGF). VEGF overexpression leads to abnormal growth of choroidal neovascularization (CNV), which is a hallmark of AMD. Although anti-VEGF agents are effective in treating nAMD, long-term efficacy decreases over time due to the need for repeated injections impacting patient compliance with treatment regimen while patients still may lose vision during the 7th or 8th year of treatment. These frequent intravitreal injections can increase the risk of complications, including submacular hemorrhage, intraocular hypertension, inflammation, and retinal detachment. Furthermore, there are up to 46% of nAMD patients using anti-VEGF agents who have shown poor response or have developed tachyphylaxis with anti-VEGF therapies. HG202 is a CRISPR/Cas13 RNA-editing therapy packaging novel high-fidelity Cas13 technology using one single AAV vector to partially knock-down the expression of VEGFA and thus inhibit CNV formation in AMD patients who are either responsive or non-responsive to anti-VEGF agents. The long-term, stable delivery of HG202 following a one (1) time gene-editing therapy treatment for nAMD could potentially reduce the frequent injection treatment burden of currently available therapies AND treat nAMD patients who are non-responsive to anti-VEGF therapies and have no treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HG202 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HG202 | Genetic | Method of Administration: Once unilateral subretinal injection; The duration of the study is about 52 weeks for each subject including a 4 weeks screening period, enrollment/baseline visit, treatment visit and 48 weeks follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular and systemic adverse events | Number of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular and systemic adverse events | Number of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) | 48 weeks |
| Change from baseline in best-corrected visual acuity (BCVA) |
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Inclusion Criteria:
RESPONSIVE SUBJECTS:
NON-RESPONSIVE SUBJECTS:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | +86 021-25076143 | HG20201@huidagene.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Huidagene Therapeuticd Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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Change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart in the study eye at different doses
| 24 and 48 weeks |
| Change from baseline in central retinal thickness (CRT) | Change from baseline in central retinal thickness (CRT) as measured by optical coherence tomography (OCT) in the study eye at different doses | 24 and 48 weeks |
| Change From baseline in annualized rate of supplemental injections | Change from baseline in the number of anti-VEGF injections which is annualized to a per year rate in the study eye at different doses | 48 weeks |
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjing | China |
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