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

Tasly Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Age-related Macular Degeneration

Treatments

Drug: Sanhuangjingshimingwan Placebo

Drug: Sanhuangjingshimingwan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04486963

TSL-TCM-SHJSMW-IIa

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No 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.