A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Oxurion
- 入组人数
- 16
- 试验地点
- 25
- 主要终点
- Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
研究概览
简要总结
This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).
详细描述
In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg.
In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.
In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.
All subjects in the study will receive study treatment in one selected study eye only.
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
- •Written informed consent obtained from the subject prior to screening procedures
- •Male or female aged 18 years or older at the time of signing the informed consent
- •Type 1 or type 2 diabetes
- •BCVA ETDRS letter score ≥ 39 in the study eye
- •CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
- •BCVA ETDRS letter score ≥ 34 in the fellow eye
排除标准
- •Macular edema due to causes other than DME in the study eye
- •Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- •Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
- •Previous confounding medications / interventions, or their planned administration during the study
- •Presence of iris neovascularisation in the study eye
- •Uncontrolled glaucoma in the study eye
- •Previously received THR-687 or any other experimental therapy for DME, in either eye
- •Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- •Untreated Diabetes
- •Glycated haemoglobin A (HbA1c) > 12%
- •Uncontrolled hypertension
研究组 & 干预措施
Part A, THR-687 1.2 mg
干预措施: THR-687 dose level 1 (Drug)
Part A, THR-687 2.0mg
干预措施: THR-687 dose level 2 (Drug)
Part B, treatment naïve subjects, THR-687 selected dose level
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
干预措施: THR-687 selected dose level (Drug)
Part B, treatment naïve subjects, aflibercept 2.0mg
干预措施: Aflibercept (Drug)
Part B, previously treated subjects, THR-687 selected dose level
Due to the discontinuation of the study after Part A, the dose level for Part B has not been selected
干预措施: THR-687 selected dose level (Drug)
Part B, previously treated subjects, aflibercept 2.0mg
干预措施: Aflibercept (Drug)
结局指标
主要结局
Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
时间窗: At Month 3
次要结局
- Weighted Average of the Change From Baseline in BCVA ETDRS Letter Score From Day 8 Through Month 3 Using the Trapezoidal Rule (AUC), in Treatment-naïve Subjects in Part B of the Study(at Month 3)
- Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study(Up to Month 8)
- Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to End of Study (Part A up to Month 6 and Part B up to Month 8))
- Change From Baseline in Central Subfield Thickness (CST), Based on Spectral Domain Optical Coherence Tomography (SD-OCT), as Assessed by the Central Reading Center (CRC), by Study Visit, in Treatment-naïve Subjects in Part B of the Study(Up to Month 8)