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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
TK001 will be administered intravitreal injection.
Chinese Academy of Medicine Sciences,Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHenan Province People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGShangHai General Hospital
Shanghai, Shanghai Municipality, China
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
Time frame: 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
Time frame: 40 weeks
Area under the plasma concentration-time curve (AUC)
Core Study
Time frame: 12 weeks
Maximum plasma concentration (Cmax)
Core Study
Time frame: 12 weeks
Time to reach maximum concentration (Tmax)
Core Study
Time frame: 12 weeks
Elimination half-Life (T½)
Core Study
Time frame: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the mean central retinal thickness at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the thickness of choroidal neovascularization at 12 weeks
Core Study
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe Eye Hospital of WMU(Zhejiang eye hospital)
Wenzhou, Zhejiang, China
NOT_YET_RECRUITINGTime frame: 12 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in macular volume at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the area of choroidal neovascularization at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the area of leakage at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the total lesion size at 12 weeks
Core Study
Time frame: 12 weeks
Percentage of Participants Positive for anti-TK001 antibody at 12 weeks
Core Study
Time frame: 12 weeks
Change from baseline in the Best Corrected Visual Acuity at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the mean central retinal thickness at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the thickness of choroidal neovascularization at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the retinal thickness in the site of lesion which was the thickest at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in macular volume at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the area of choroidal neovascularization at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the area of leakage at 52 weeks
Extension Study
Time frame: 40 weeks
Change from baseline in the total lesion size at 52 weeks
Extension Study
Time frame: 40 weeks
Percentage of Participants Positive for anti-TK001 antibody at 52 weeks
Extension Study
Time frame: 40 weeks