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A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sanhuangjingshimingwan

Sanhuangjingshimingwan Placebo

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring wAMD

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients must meet the following criteria for entry into the trail:
1. Meet the diagnostic criteria for wAMD.
2. Meet the Traditional Chinese Medicine diagnostic criteria for Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome.
3. Presence of choroidal neovascularization secondary to wAMD, and/or simple eye with blood, edema, leakage, hard exudation in or below the retina, and detachment of retinal pigment epithelium or neuroepithelium epithelium.
4. 50 years≤Age≤80 years of either gender.
5. BCVA 25 - 78 ETDRS letters(0.06~0.6, inclusive).
6. Signed informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from study entry:
1. Presence of pathological myopia,high myopia caused of secondary choroidal neovascularization, glaucoma, diabetic retinopathy, retinal arteriovenous obstruction, optic neuropathy (optic neuritis, atrophy, papillary edema), macular hole, acute phase of intraocular inflammation.
2. Only retinal pigment epithelium-retinal detachment.
3. The CNV area is more than 12 optic disk area (30mm2).
4. Subfoveal structural damage or fibrosis.
5. Subjects that have unclear refractive stroma(e.g.vitreous hemorrhage, cataracts) caused fundus observation difficulty or undergone vitrectomy.
6. Subjects that have presence of other causes of choroidal neovascularization.
7. Subjects that have participated in other study of treatment with study drug within the last 3 months before the screening.
8. Subjects that have treated with photodynamic therapy, external beam radiological therapy, argon laser photocoagulation in macular area, macular surgery, transpupillary thermotherapy, hormone to treat wAMD in any eye within the last 6 months before the screening.
9. Subjects that have undergone previous any eye surgery(except eyelid surgery).
10. Subjects that have intravitreal anti-VEGF injections in the past 3 months.
11. Subjects with history of fundus fluorescein and indocyanine green allergy.
12. Subjects that have any contraindications in the directions of ranibizumab(LUCENTIS)injection.
13. Subjects that have had severe heart disease in the last 6 months,such as congestive heart failure，unstable angina，acute coronary syndrome，myocardial infarction，Coronary revascularization，artery thrombosis, and ventricular arrhythmia that need treatment.
14. Subjects with uncontrolled hypertension（After antihypertension treatment SBP≥140mmHg、DBP≥90mmHg）.
15. PLT≤100×109/L; Coagulation function disorders;TBIL（Total Bilirubin）>1.5×UNL（Upper Limits of Normal）;ALT（Alanine Transaminase）>2.5×UNL or AST（Aspartate aminotransferase）>2.5×UNL;Cr（Creatinine）>1.5×UNL.
16. Subjects with uncontrolled disease history, such as serious mental, neurological, respiratory, immune, blood and other system diseases, malignant tumors and that not suitable for the study per the investigator's judgment.

Sites / Locations

Beijing Hospital
Beijing Tongren Hospital
The Second Hospital of Hebei Medical University
Shanghai General Hospital
Tianjin Eye Hospital
Tianjin Medical University Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sanhuangjingshimingwan group

Sanhuangjingshimingwan Placebo group

Arm Description

Sanhuangjingshimingwan,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.

Sanhuangjingshimingwan placebo,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Change from Baseline in Central Retinal Thickness (CRT)

Change from Baseline in CRT as measured by Optical Coherence Tomography (OCT) over the study duration.

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.

Change from Baseline in leakage area

Change from Baseline in leakage area as measured by Fluorescein Angiography (FA) 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.

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).

Change from Baseline in the effective TCM syndrome scores

Full Information

NCT ID

NCT04486963

First Posted

July 22, 2020

Last Updated

November 22, 2022

Sponsor

Tasly Pharmaceutical Group Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04486963

Brief Title

A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects

Official Title

A Randomized, Double-blind, Placebo-controlled, Ranibizumab Injected, Multicenter Phase II Clinical Study on the Efficacy and Safety of Sanhuangjingshimingwan in the Wet AMD(Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome )Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 24, 2020 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

wAMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sanhuangjingshimingwan group

Arm Type

Experimental

Arm Description

Sanhuangjingshimingwan,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.

Arm Title

Sanhuangjingshimingwan Placebo group

Arm Type

Placebo Comparator

Arm Description

Sanhuangjingshimingwan placebo,12g/bag,1 bag,Bid.Anti VEGF injection will be injected monthly if needed.

Intervention Type

Drug

Intervention Name(s)

Sanhuangjingshimingwan

Intervention Description

Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.

Intervention Type

Drug

Intervention Name(s)

Sanhuangjingshimingwan Placebo

Intervention Description

Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.

Primary Outcome Measure Information:

Title

The average number of reinjections

Description

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

Secondary Outcome Measure Information:

Title

The percentage of subjects in both arms receiving reinjection of Anti-VEGF injection

Description

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

Title

The average number of days between the second injection and baseline injection

Description

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

Title

Change from baseline in BCVA

Description

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

Title

The BCVA increasing >5, >10 and > 15 letters change from baseline

Description

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

Title

The BCVA decreasing<5, <10 and < 15 letters change form baseline

Description

The proportion of subjects who decreased 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

Title

The BCVA decreasing≥15, ≥30 letters change form baseline

Description

The proportion of subjects who decreased BCVA ≥15, ≥30 letters at 24 week compared with the baseline.

Time Frame

at week 24

Title

Change from Baseline in Central Retinal Thickness (CRT)

Description

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

Title

Change from Baseline in Choroidal Neovascularization (CNV) area

Description

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

Title

Change from Baseline in leakage area

Description

Change from Baseline in leakage area as measured by Fluorescein Angiography (FA) at week 24.

Time Frame

at week 24

Title

Change from Baseline in the number of polypoid choroidal vasculopathy(PCV) and Branching vascular network(BVN) area

Description

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

Title

Change from Baseline in TCM(Traditional Chinese Medicine) syndrome scores

Description

Time Frame

at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

Title

Change from Baseline in the effective TCM syndrome scores

Description

Time Frame

at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients must meet the following criteria for entry into the trail: Meet the diagnostic criteria for wAMD. Meet the Traditional Chinese Medicine diagnostic criteria for Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome. Presence of choroidal neovascularization secondary to wAMD, and/or simple eye with blood, edema, leakage, hard exudation in or below the retina, and detachment of retinal pigment epithelium or neuroepithelium epithelium. 50 years≤Age≤80 years of either gender. BCVA 25 - 78 ETDRS letters(0.06~0.6, inclusive). Signed informed consent form. Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from study entry: Presence of pathological myopia,high myopia caused of secondary choroidal neovascularization, glaucoma, diabetic retinopathy, retinal arteriovenous obstruction, optic neuropathy (optic neuritis, atrophy, papillary edema), macular hole, acute phase of intraocular inflammation. Only retinal pigment epithelium-retinal detachment. The CNV area is more than 12 optic disk area (30mm2). Subfoveal structural damage or fibrosis. Subjects that have unclear refractive stroma(e.g.vitreous hemorrhage, cataracts) caused fundus observation difficulty or undergone vitrectomy. Subjects that have presence of other causes of choroidal neovascularization. Subjects that have participated in other study of treatment with study drug within the last 3 months before the screening. Subjects that have treated with photodynamic therapy, external beam radiological therapy, argon laser photocoagulation in macular area, macular surgery, transpupillary thermotherapy, hormone to treat wAMD in any eye within the last 6 months before the screening. Subjects that have undergone previous any eye surgery(except eyelid surgery). Subjects that have intravitreal anti-VEGF injections in the past 3 months. Subjects with history of fundus fluorescein and indocyanine green allergy. Subjects that have any contraindications in the directions of ranibizumab(LUCENTIS)injection. Subjects that have had severe heart disease in the last 6 months,such as congestive heart failure，unstable angina，acute coronary syndrome，myocardial infarction，Coronary revascularization，artery thrombosis, and ventricular arrhythmia that need treatment. Subjects with uncontrolled hypertension（After antihypertension treatment SBP≥140mmHg、DBP≥90mmHg）. PLT≤100×109/L; Coagulation function disorders;TBIL（Total Bilirubin）>1.5×UNL（Upper Limits of Normal）;ALT（Alanine Transaminase）>2.5×UNL or AST（Aspartate aminotransferase）>2.5×UNL;Cr（Creatinine）>1.5×UNL. Subjects with uncontrolled disease history, such as serious mental, neurological, respiratory, immune, blood and other system diseases, malignant tumors and that not suitable for the study per the investigator's judgment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rui Liu

Organizational Affiliation

Tasly Group, Co. Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Hospital

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Beijing Tongren Hospital

City

Beijing

State/Province

Beijing

Country

China

Facility Name

The Second Hospital of Hebei Medical University

City

Shijiazhuang

State/Province

Hebei

Country

China

Facility Name

Shanghai General Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Facility Name

Tianjin Eye Hospital

City

Tianjin

State/Province

Tianjin

Country

China

Facility Name

Tianjin Medical University Eye Hospital

City

Tianjin

State/Province

Tianjin

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects

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