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

NCT04486963 | Completed Phase 2

• 1 other identifier: TSL-TCM-SHJSMW-IIa
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Age-related Macular Degeneration

Keywords

wAMD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

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

  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

  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

  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

  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

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

Study Arms (2)

Sanhuangjingshimingwan group

EXPERIMENTAL

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

Drug: Sanhuangjingshimingwan

Sanhuangjingshimingwan Placebo group

PLACEBO COMPARATOR

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

Drug: Sanhuangjingshimingwan Placebo

Interventions

Sanhuangjingshimingwan DRUG

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

Sanhuangjingshimingwan group

Sanhuangjingshimingwan Placebo DRUG

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

Sanhuangjingshimingwan Placebo group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years≤Age≤80 years of either gender.
• BCVA 25 - 78 ETDRS letters(0.06\~0.6, inclusive).
• Signed informed consent form.

You may not qualify if:

• 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）.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (6)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Rui Liu

  Tasly Group, Co. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: July 24, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 15, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

CN (6)