NCT05562219已完成2 期
A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase II Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration
Smilebiotek Zhuhai Limited1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 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 2, 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.
详细描述
Approximately 12 sites will randomize a total of approximately 120 subjects . The subject randomization code table is generated using block randomization. Randomization of not less than 120 cases receiving treatment (treatment and placebo groups) at a ratio of 1:1 for the treatment and control groups.
Clinic study visits will occur on Day -7 to Day -1(Screening/Baseline)(Randomization); Treatment Visits for weeks 4, 8, 12,16,20,and 24 (all ± 3 days); sites will contact each subject to update efficacy date and adverse events (AEs) and review concomitant medications (CMs).
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
- 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 is diagnosed by western medicine with intermediate age-related macular degeneration, i.e., at least one large drusen (≥ 125 μm in diameter) is visible within two papillary diameters (PD) away from the fovea;
- •Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
- •Age 45 to 85 years old (both inclusive), male or female;
- •The study eye has a BCVA of 83-34 ETDRS letters (inclusive), which is equivalent to a Snellen visual acuity of 20/25 to 20/200 (inclusive);
- •The subject is voluntary to participate in this clinical study, provide informed consent, and sign the informed consent form.
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;
- •The study eye is presented with GA;
- •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 or periocular surgery of the study eye and intraocular surgery (except eyelid surgery) of the non-study eye within 3 months;
- •The study eye is diagnosed with cataract affecting fundus observation, which may require cataract surgery within 6 months at the discretion of the investigator;
- •The study eye has received the following treatment within 3 months prior to screening: macular laser photocoagulation and micro-pulse laser therapy;
- •The patient received relevant TCM treatment within 1 month prior to screening;
- •Active ocular infection in either eye;
- •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);
- •Patients with platelet count ≤ 100 × 109/L, total bilirubin (TBIL) > upper limit of normal (ULN), alanine transaminase (ALT) or aspartate aminotransferase (AST) > 1.5 × ULN, and blood creatinine > ULN;
- •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
Treatment group(QA108 granules)
Experimental
QA108 granules, 7.5 g/bag,2 bags/time, BID
干预措施: QA108 granules (Drug)
Placebo group(QA108 granule simulants)
Placebo Comparator
QA108 granule simulants, 7.5 g/bag,2 bags/time, BID
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
1. change from baseline in drusen area as measured by optical coherence tomography (OCT) 2. assessments will be conducted by the central reading center (CRC)
次要结局
- Percentage change from baseline in drusen area(weeks 4,8,12,16,20)
研究者
研究点 (1)
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