A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxurion
- 入组人数
- 135
- 试验地点
- 78
- 主要终点
- Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
研究概览
简要总结
Part A of the study is conducted to select the THR-149 dose level.
Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
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 ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
- •Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
- •Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
- •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 central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- •Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
- •Previous confounding medications / interventions, or their planned administration
- •Presence of neovascularisation at the disc in the study eye
- •Presence of iris neovascularisation in the study eye
- •Uncontrolled glaucoma in the study eye
- •Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- •Untreated Diabetes Mellitus
- •Glycated haemoglobin A (HbA1c) > 12%
- •Uncontrolled hypertension
研究组 & 干预措施
THR-149 dose level 1
干预措施: THR-149 dose level 1 (Drug)
THR-149 dose level 2
干预措施: THR-149 dose level 2 (Drug)
THR-149 dose level 3
干预措施: THR-149 dose level 3 (Drug)
THR-149 + sham
干预措施: THR-149 0.13mg (Drug)
THR-149 + aflibercept flip-over
干预措施: THR-149 0.13mg + aflibercept 2mg (Drug)
Aflibercept + THR-149 flip-over
干预措施: aflibercept 2mg + THR-149 0.13mg (Drug)
Aflibercept + sham
干预措施: Aflibercept 2mg (Drug)
结局指标
主要结局
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
时间窗: At Month 3
次要结局
- Mean change in BCVA ETDRS letter score from Baseline, by study visit(Up to Month 6)
- Mean change in central subfield thickness (CST) from Baseline, by study visit(Up to Month 6)
- Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)(Up to Month 6)