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| Name | Class |
|---|---|
| Tianjin Medical University Eye Hospital | OTHER |
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Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT520FF dose level 1 treatment | Experimental | SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously |
|
| SCT520FF dose level 2 treatment | Experimental | SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously |
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| SCT520FF dose level 3 treatment | Experimental | SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously |
|
| eylea 2 mg | Active Comparator | eylea 2 mg,IVI,injection once every 4 weeks,during the study period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT520FF | Drug | SCT520FF dose level 1，IVI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events(TEAE) | Incidence of treatment emergent adverse events | From Day 0 up to 196days |
| Treatment-related treatment emergent adverse events(TRAE) | Incidence of treatment-related treatment emergent adverse events | From Day 0 up to 196days |
| Serious adverse event(SAE) | Incidence of serious adverse event | From Day 0 up to 196days |
| Adverse event of special interest(AESI) | Incidence of adverse event of special interest | From Day 0 up to 196days |
| Dose limited toxicity(DLT) | Incidence of dose-limiting toxicities | From Day 0 up to 196days |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity(BCVA) | Mean change from baseline in BCVA | Day 0 up to 196 days |
| central retina thickness(CRT) | Mean change from baseline in CRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Xiaorong | Contact | +86-18626789043 | 35479080@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjing | China |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| SCT520FF |
| Drug |
SCT520FF dose level 2，IVI |
|
| SCT520FF | Drug | SCT520FF dose level 3，IVI |
|
| EYLEA 2 MG | Drug | EYLEA 2 MG,IVI,injection once every 4 weeks,during the study period |
|
| Day 0 up to 196days |
| PK profile | Change of SCT520FF drug concentration in the blood with time | Day 0 up to 196days |
| Cmax | The maximum blood concentration after SCT520FF drug enters the bloodstream | Day 0 up to 196days |
| Tmax | Time to the Maximum Concentration of SCT520FF | Day 0 up to 196days |
| PD profile | Detection of free VEGF concentration | Day 0 up to 196 days |
| Immunogenicity | Positive rate of ADA and NAb | Day 0 up to 196days |