jRCT2071250009招募中不适用
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO EVALUATE THE EFFICACY, AND SAFETY OF FARICIMAB IN PATIENTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (AZUSA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 主要终点
- Proportion of study participants achieving >= 2-step improvement from baseline in ETDRS-DRSS
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •General Inclusion Criteria
- •Patients aged 18 years or older at the time of informed consent
- •Patients who had a documented diagnosis of diabetes mellitus (type 1 or 2) according to the definition of the Japan Diabetes Society or the WHO criteria and who met both or either of the following criteria
- •Use of insulin or other injectable drugs (dulaglutide, liraglutide, etc.) for diabetes on a regular basis for 3 months prior to Day 1
- •Use of an oral hypoglycemic agent for the treatment of diabetes on a regular basis for 3 months prior to Day 1
- •Females of childbearing potential: Patients must agree to be abstinent from heterosexual intercourse or to use a method of contraception with a failure rate of less than 1% per year during the active treatment period and for 3 months after the last dose of active treatment or rescue dose of 6 mg faricimab, and must agree to refrain from donating eggs during this period.
- •Study Eye Inclusion Criteria
- •Moderate or severe NPDR (ETDRS-DRSS 47 or 53) as determined by the Investigator and confirmed by the central reading center at Screening.
- •Patient must not have CI-DME(CST >= 325 mcm as measured by Spectralis SD-OCT or CST >= 315 mcm as measured by Cirrus SD-OCT or Topcon SS-OCT) as assessed by the Investigator and confirmed by the Central reading center at Screening.
- •BCVA of 65 letters (Snellen visual acuity 20/50, decimal visual acuity 0.4) or better on the ETDRS visual acuity test assessed at a starting distance of 4 meters on Day 1 (refer to the Ophthalmology Examination Manual for details).
- •Adequately clear optic media and fully dilated pupils for analysis and evaluation by the central reading center.
排除标准
- •General Exclusion Criteria
- •Patients who need to use prohibited concomitant therapies during the study period
- •Patients with screening HbA1c > 12%, or patients with HbA1c =< 12% but with uncontrolled diabetes in the opinion of the investigator
- •Uncontrolled blood pressure (Defined as resting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) at Day
- •History of any other ocular condition that could reasonably contraindicate the use of faricimab, that could confound the interpretation of the study results, or that could put the patient at increased risk of complications
- •Women who are pregnant or breastfeeding, or intending to become pregnant during the study
- •Patients with history of severe allergic or anaphylactic reactions to biologics or known hypersensitivity to faricimab ingredients, study procedures, dilating drops, anesthetics and antibiotics the patient will use during the study
- •Participation in any clinical study using a drug (except vitamins and minerals) or device within 3 months prior to Day 1
- •Study Eye Exclusion Criteria
- •Patients with prior Intravitreal Anti-VEGF Therapy
- •Patients with prior intravitreal or periocular (sub-Tenon's) steroid therapy, panretinal photocoagulation (PRP), selective photocoagulation or macular laser photocoagulation.
结局指标
主要结局
Proportion of study participants achieving >= 2-step improvement from baseline in ETDRS-DRSS
时间窗: Week 48
Proportion of study participants achieving >= 2-step improvement from baseline in ETDRS-DRSS at Week 48
次要结局
未报告次要终点
研究者
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