The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.
The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan,give two times a day versus placebo in wAMD .The clinical phase of the study comprises a 6-months double-blind treatment period, resulting in 6.5-months overall duration of the study for each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The average number of reinjections
The subject is injected with Anti-VEGF（Vascular Endothelial Growth Factor） injection once 4 weeks if needed.Compare with the average shoot number of Anti-VEGF injections in both arms.
Time frame: at week 24
The percentage of subjects in both arms receiving reinjection of Anti-VEGF injection
The subject is injected with Anti-VEGF injection once weeks if needed.Compare with the percentage of subjects who reinjected Anti-VEGF injections in both arms.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
The average number of days between the second injection and baseline injection
The subject is injected with Anti-VEGF injection once 4 weeks if needed.Compare with the average number of days between the second injection and baseline injection in both arms.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Change from baseline in BCVA
The subject is tested the vision(BCVA) once 4 weeks with ETDRS visual chart.Compare every visit BCVA with baseline BCVA.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
The BCVA increasing >5, >10 and > 15 letters change from baseline
The proportion of subjects who increased BCVA \>5, \>10 and \> 15 letters at each visit compared with the baseline.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
The BCVA decreasing<5, <10 and < 15 letters change form baseline
The proportion of subjects who decreased BCVA \<5, \<10 and \<15 letters at each visit compared with the baseline.
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Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
The BCVA decreasing≥15, ≥30 letters change form baseline
The proportion of subjects who decreased BCVA ≥15, ≥30 letters at 24 week compared with the baseline.
Time frame: at week 24
Change from Baseline in Central Retinal Thickness (CRT)
Change from Baseline in CRT as measured by Optical Coherence Tomography (OCT) over the study duration.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Change from Baseline in Choroidal Neovascularization (CNV) area
Change from Baseline in CNV area as measured by Optical Coherence Tomography Angiography(OCTA) over the study duration.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Change from Baseline in leakage area
Change from Baseline in leakage area as measured by Fluorescein Angiography (FA) at week 24.
Time frame: at week 24
Change from Baseline in the number of polypoid choroidal vasculopathy(PCV) and Branching vascular network(BVN) area
Change from Baseline in the number of PCV and BVN area as measured by Indocyanine Green Angiography(ICGA) over the study duration.
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Change from Baseline in TCM(Traditional Chinese Medicine) syndrome scores
The title of the scale is Traditional Chinese Medicine Syndrome Scale.Compared wth baseline,the scores of changes of TCM syndrome evaluation at each visit .This scale consists of two primary symptoms: Blurred vision and Metamorphopsia,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3） respectively. The final score has a range of 0（none）to 42（severe）.TCM syndrome effect calculated by nimodipine method.The effect of TCM syndrome from negative (worsen) to 100% (disappear).
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Change from Baseline in the effective TCM syndrome scores
The title of the scale is Traditional Chinese Medicine Syndrome Scale.Compared wth baseline,the scores of changes of TCM syndrome evaluation at each visit .This scale consists of two primary symptoms: Blurred vision and Metamorphopsia,and four secondary symptoms.Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3） respectively. The final score has a range of 0（none）to 42（severe）.TCM syndrome effect calculated by nimodipine method.The effect of TCM syndrome from negative (worsen) to 100% (disappear).
Time frame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24