Status:
COMPLETED
A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04486963
Start Date
July 24 2020
End Date
November 15 2022
Last Update
November 25 2022
Active Locations (6)
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1
Beijing Hospital
Beijing, Beijing Municipality, China
2
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
3
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
4
Shanghai General Hospital
Shanghai, Shanghai Municipality, China