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This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks).
This is a multicenter, open-label study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of multiple intravitreal injection TK001 in patients with AMD. It consists of core study (12 weeks) and extension study (40 weeks). In the core study, patients will receive their assigned dose in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. The safety, pharmacokinetics, immunogenicity, and preliminary efficacy of TK001 will be evaluated in the core study, and will also be assessed in the extension study except pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg | Experimental | In the core study, patients will receive 0.5mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. |
|
| 1.0mg | Experimental | In the core study, patients will receive 1.0mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. |
|
| 1.5mg | Experimental | In the core study, patients will receive 1.5mg TK001 in a 50-μL solution administered as an intravitreal injection every 4 weeks. In the extension study, they will be evaluated every 4 weeks and administrated PRN (pro re nata) with their assigned dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TK001 | Biological | TK001 will be administered intravitreal injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the first 12 weeks | Core Study | 12 weeks |
| Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001 in the following 40 weeks | Extension Study | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | Core Study | 12 weeks |
| Maximum plasma concentration (Cmax) | Core Study | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Limitation of eye diseases
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongwei Miao | Contact | +86(21)61160520 | miaohongwei@sh-qingfeng.net |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhang | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medicine Sciences，Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Time to reach maximum concentration (Tmax) | Core Study | 12 weeks |
| Elimination half-Life (T½) | Core Study | 12 weeks |
| Change from baseline in the Best Corrected Visual Acuity at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the mean central retinal thickness at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the thickness of choroidal neovascularization at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks | Core Study | 12 weeks |
| Change from baseline in macular volume at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the area of choroidal neovascularization at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the area of leakage at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the total lesion size at 12 weeks | Core Study | 12 weeks |
| Percentage of Participants Positive for anti-TK001 antibody at 12 weeks | Core Study | 12 weeks |
| Change from baseline in the Best Corrected Visual Acuity at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the mean central retinal thickness at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the thickness of choroidal neovascularization at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in macular volume at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the area of choroidal neovascularization at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the area of leakage at 52 weeks | Extension Study | 40 weeks |
| Change from baseline in the total lesion size at 52 weeks | Extension Study | 40 weeks |
| Percentage of Participants Positive for anti-TK001 antibody at 52 weeks | Extension Study | 40 weeks |
| Henan Province People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| ShangHai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610047 | China |
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| The Eye Hospital of WMU(Zhejiang eye hospital) | Not yet recruiting | Wenzhou | Zhejiang | 325027 | China |
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