NCT07189169招募中3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration (Type of Yang-Hyperactivity Due to Yin-Deficiency)
Smilebiotek Zhuhai Limited1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年7月8日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in drusen area
研究概览
简要总结
This is a phase III randomized, double-masked, placebo-controlled, multicenter study. To evaluate the efficacy and safety of QA108 granules in the treatment of intermediate age-related macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration;
- •Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus;
- •Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- •Age 45-85 years (inclusive), regardless of gender;
- •The study eye has a BCVA of 88-34 letters (using the ETDRS chart, inclusive of threshold values), equivalent to a Snellen visual acuity of 20/20 to 20/200 (inclusive);
- •Voluntary participation in this clinical trial, with informed consent provided and an informed consent form signed
排除标准
- •The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macular hole;
- •The study eye has an intraocular pressure (IOP) ≥ 25 mmHg;
- •Presence of geographic atrophy (GA) involving the foveal center in the study eye;
- •Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;
- •Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) of the study eye;
- •Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months;
- •Cataract in the study eye that interferes with fundus examination or imaging;
- •Treatments received in the study eye within 3 months prior to screening, including macular laser photocoagulation and micropulse laser therapy;
- •The patient received relevant TCM treatment within 1 month prior to screening;
- •Active ocular infection in either eye that affects fundus examination or imaging;
- •The non-study eye has a BCVA of less than 19 ETDRS letters (not inclusive);
- •Known allergy to the therapeutic or diagnostic drug used in the study protocol, including the single drug components in the study drugs;
- •Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after regular use of antihypertensive drugs);
- •Platelet count ≤100×10⁹/L (unless follow-up results are normal), or any of the following exceeding 1.5 times the upper limit of normal (ULN): total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine (Cr);
- •Pregnant women, women who are breastfeeding, those who plan for pregnancy in the next six months, or those who are unwilling to take effective birth controls during the study course and until six months after drug withdrawal;
- •Any uncontrollable clinical disorder prior to the start of treatment, such as severe psychiatric, neurological, respiratory, immunological, hematological, and cardiac system diseases, and malignant tumors;
- •Subjects who have participated in other clinical trials within 3 months prior to this trial;
- •Patients who are unsuitable for participating at the discretion of the investigator.
研究组 & 干预措施
QA108 granules, 7.5 g/bag,2 bags/time, BID
Experimental
干预措施: QA108 granules (Drug)
QA108 granule simulants, 7.5 g/bag,2 bags/time, BID
Placebo Comparator
干预措施: QA108 granules placebo (Drug)
结局指标
主要结局
Percentage change from baseline in drusen area
时间窗: weeks 24
次要结局
- Percentage change from baseline in drusen area(weeks 12)
研究者
研究点 (1)
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