Clinical trial NCT04486963: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-related Macular Degeneration
Keywords: wAMD
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The average number of reinjections
timeFrame: at week 24
Secondary outcomes:
measure: The percentage of subjects in both arms receiving reinjection of Anti-VEGF injection
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: The average number of days between the second injection and baseline injection
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: Change from baseline in BCVA
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: The BCVA increasing >5, >10 and > 15 letters change from baseline
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: The BCVA decreasing<5, <10 and < 15 letters change form baseline
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: The BCVA decreasing≥15, ≥30 letters change form baseline
timeFrame: at week 24
measure: Change from Baseline in Central Retinal Thickness (CRT)
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: Change from Baseline in Choroidal Neovascularization (CNV) area
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: Change from Baseline in leakage area
timeFrame: at week 24
measure: Change from Baseline in the number of polypoid choroidal vasculopathy(PCV) and Branching vascular network(BVN) area
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: Change from Baseline in TCM(Traditional Chinese Medicine) syndrome scores
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
measure: Change from Baseline in the effective TCM syndrome scores
timeFrame: at screening;at week 4;at week 8;at week 12;at week 16;at week 20;at week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Eye Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
affiliation: Tasly Group, Co. Ltd.
name: Rui Liu
role: STUDY_DIRECTOR
References: