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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
| Tianjin Medical University Eye Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
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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 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline | At Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
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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 |
|---|---|---|
| Peirong Lu, Professor | The First Affiliated Hospital of Soochou University | Principal Investigator |
| Xiaorong Li, Professor | Tianjin Medical University Eye Hospital | Principal Investigator |
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| The First Affiliated Hospital of Zhengzhou University |
| OTHER |
Neovascular Age-related Macular Degeneration
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| Hanyi Min |
| Peking Union Medical College Hospital |
| Principal Investigator |
| Guangming Wan | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |