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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sanhuangjingshimingwan group | Experimental | Sanhuangjingshimingwan,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed. |
|
| Sanhuangjingshimingwan Placebo group | Placebo Comparator | Sanhuangjingshimingwan placebo,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sanhuangjingshimingwan | Drug | Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24 |
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Inclusion Criteria:
All patients must meet the following criteria for entry into the trail:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from study entry:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Liu | Tasly Group, Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Tongren Hospital |
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| Sanhuangjingshimingwan Placebo | Drug | Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24 |
| Beijing |
| Beijing Municipality |
| China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
| Tianjin Eye Hospital | Tianjin | Tianjin Municipality | China |
| Tianjin Medical University Eye Hospital | Tianjin | Tianjin Municipality | China |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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