NCT07269769尚未招募3 期
A Phase III , Randomized, Double-blind, Placebo-Controlled, Ranibizumab Injection Loading, Multicenter Clinical Trial Comparing the Efficacy and Safety of Sanhuang Jingshiming Pills in Subjects With nAMD
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Proportion of participants with ranibizumab injections
研究概览
简要总结
The purpose of the TSL-TCM-SHJSMW-Ⅲ study is to study the efficacy and safety of Sanhuang Jingshiming Pills in subjects with Neovascular Age-Related Macular Degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 to 85 years old (inclusive of 50 and 85 years old)
- •Meets the Western medical diagnostic criteria for neovascular age-related macular degeneration
- •Meets the TCM syndrome differentiation criteria for Qi-Yin Deficiency with Phlegm-Blood Stasis Intermingling Syndrome
- •The study eye is diagnosed with nAMD and the disease is in the active phase
- •BCVA of the study eye assessed by the ETDRS visual acuity chart ranges from 25 to 78 letters
- •Voluntarily participates in the clinical trial, signs the ICF, and is able to understand and comply with the trial procedures
排除标准
- •The study eye is complicated with pathologic myopia, high myopia, or secondary MNV caused by other definite diseases, glaucoma, diabetic retinopathy , retinal artery/vein occlusion , optic neuropathy (optic neuritis, optic atrophy, papilledema), macular hole, acute phase of intraocular inflammation, or other ocular diseases
- •Patients with pure PED in the study eye
- •Patients with subfoveal structural destruction or subfoveal fibrosis/scars/RPE tear/GA in the study eye
- •Patients whose FP of the study eye shows a total macular lesion area > 9 disc areas (total lesion area is defined as the sum of the areas of MNV, atrophy, scars, and fibrosis); or patients whose FP of the study eye shows a maximum macular hemorrhage area > 4 disc areas
- •Patients with CRT ≥ 700 μm in the study eye as assessed by OCT
- •Patients with opaque refractive media (e.g., vitreous hemorrhage, cataract) in the study eye precluding adequate visualization of the fundus, or with a history of vitrectomy
- •Patients planning to undergo any intraocular surgery on the study eye during the trial period
- •Patients who received pharmacologic treatment for nAMD within 2 weeks prior to randomization
- •Patients who received intravitreal anti-vascular endothelial growth factor therapy on the study eye within 4 months prior to randomization
- •Patients who received photodynamic therapy , laser photocoagulation, macular surgery, transpupillary thermotherapy , or corticosteroid therapy on the study eye within 6 months prior to randomization
- •Patients who underwent any intraocular or periocular surgery (excluding eyelid surgery) on the study eye within 3 months prior to randomization
- •Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg while on regular antihypertensive medication)
- •History of major cardiovascular or cerebrovascular diseases, including but not limited to: ① history of myocardial infarction (MI), coronary angioplasty or bypass surgery, valvular heart disease or valvular repair, clinically significant and treatment-requiring arrhythmia, unstable angina, transient ischemic attack (TIA), cerebrovascular accident (CVA), etc., within 6 months prior to randomization; ② congestive heart failure (CHF) with New York Heart Association (NYHA) classification of Grade Ⅲ or Ⅳ
- •Laboratory test abnormalities as follows: ① platelet count ≤ 100 × 10⁹/L; ② International Normalized Ratio (INR) ≥ 1.5; ③ total bilirubin (TBIL) > 2 × upper limit of normal (ULN); ④ alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN; ⑤ serum creatinine (Scr) > 1.5 × ULN
- •Patients with severe and unstable diseases of the mental, neurological, respiratory, digestive, renal, metabolic, immune, hematologic, or other systems, as well as malignant tumors, who are assessed by the investigator as unsuitable for participation in this clinical trial
- •Presence of any contraindications listed in the package insert of ranibizumab injection (Lucentis®) or other anti-VEGF injections
- •Suspected allergy to any study drug
- •Pregnant or lactating females; males or females who plan to conceive within 30 days from signing the ICF to the end of the trial, or who cannot use effective contraceptive measures
- •Participation in another interventional clinical trial within 3 months prior to randomization
- •Other reasons deemed unsuitable for participation in this clinical trial by the investigator
研究组 & 干预措施
Experimental Group
Experimental
Sanhuang Jingshiming Pills，1 sachet/dose, bid
干预措施: Sanhuang Jingshiming/Pills placebo (Drug)
Placebo Group
Placebo Comparator
Placebo，1 sachet/dose, bid
干预措施: Sanhuang Jingshiming/Pills placebo (Drug)
结局指标
主要结局
Proportion of participants with ranibizumab injections
时间窗: 24 weeks
次要结局
- Mean number of ranibizumab injections(24 weeks)
- Mean days between second ranibizumab injection and baseline(24 weeks)
- Change in BCVA from baseline(24 weeks)
- Proportion of participants with BCVA decrease ≥5/≥10/≥15 letters(24 weeks)
- Change in lesion site thickness(24 weeks)
- Change in CRT from baseline(24 weeks)
- Proportion of participants with new macular hemorrhage(24 weeks)
- Change in maximum macular hemorrhage area(24 weeks)
- Change in NEI VFQ-25 score from baseline(24 weeks)
- Change in TCM syndrome score from baseline(24 weeks)
- Change in individual TCM syndrome score items from baseline(24 weeks)
- Proportion of participants by TCM syndrome efficacy(24 weeks)
研究者
研究点 (1)
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