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| Name | Class |
|---|---|
| Tianjin Medical University Eye Hospital | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Peking Union Medical College Hospital | OTHER |
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The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT003 Dose 1 | Experimental | Low dose of FT-003 |
|
| FT003 Dose 2 | Experimental | Mid dose of FT-003 |
|
| FT003 Dose 3 | Experimental | High dose of FT-003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT-003 | Genetic | Administered via intraocular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after FT-003 injection | Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0) | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy after FT-003 injection | the BCVA and OCT change from baseline | At Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyan Li | Contact | 86-021-58206061 | xinyan.li@fronteratherapeutics.com | |
| Minghui Xue | Contact | 86-021-58206061 | minghui.xue@fronteratherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaorong Li, Professor | Tianjin Medical University Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin,China | 300392 | China |
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| Beijing Hospital |
| OTHER_GOV |
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