NCT05885503招募中3 期
A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change from baseline in BCVA at Week 52
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosed with type I or type II diabetes mellitus.
- •Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day
- •Ability and willingness to undertake all scheduled visits and assessments.
- •The study eye must meet the following requirements:
- •macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
- •decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
排除标准
- •The study eye with high risk of proliferative diabetic retinopathy.
- •The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
- •Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
- •Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day
- •Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day
- •Active intraocular or periocular infection or active intraocular inflammation in either eye.
- •The study eye with poorly controlled glaucoma.
- •A history of idiopathic or autoimmune related uveitis in either eye.
- •History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day
- •Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest.
- •Currently pregnant or breastfeeding, or intend to become pregnant during the study.
- •Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.
- •Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.
- •Other protocol-specified inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline in BCVA at Week 52
时间窗: Baseline, week 52
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
次要结局
- Change from baseline in CST over time(Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52(Baseline, week 52)
- Proportion of patients who develop new PDR or high risk PDR at Week 52(Baseline, week 52)
- Presence of ADAs during the study relative to the presence of ADAs at baseline(Baseline, weeks 12, 24, 36 and 52)
- Average change in BCVA from baseline over the period week 40 through week 52(Baseline, weeks 40, 44, 48 and 52)
- Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52(Baseline, week 52)
- Proportion of patients with absence of intraretinal fluid at Week 52(Baseline, week 52)
- Mean change from baseline in CST over a period of week 40 through week 52(Baseline, weeks 40, 44, 48 and 52.)
- Change from baseline in BCVA over time(Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52)
- Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52(Baseline, week 52)
- Change from baseline in CST at Week 52(Baseline, week 52)
- Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52(Baseline, week 52)
- Proportion of patients with absence of subretinal fluid at Week 52(Baseline, week 52)
- Incidence and severity of ocular adverse events and non-ocular adverse events(0~52 weeks)
- Plasma concentration of RC28-E over time(Baseline, weeks 16, 36 and 48)
研究者
研究点 (1)
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