NCT03499223已完成2 期
A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
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
- Oxurion
- 入组人数
- 70
- 试验地点
- 37
- 主要终点
- Change from baseline in BCVA
研究概览
简要总结
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).
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
- Single (Participant)
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
- •Male or female aged 18 years or older
- •Type 1 or type 2 Diabetes Mellitus
- •CI-DME with central subfield thickness of ≥ 320μm on Spectralis® SD-OCT or ≥ 305μm on non Spectralis SD-OCT, in the study eye
- •Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye
- •Reduced vision primarily due to DME, with BCVA ≤ 72 and ≥ 23 ETDRS letter score (≤ 20/40 and ≥ 20/320 Snellen equivalent) in the study eye
- •Non-proliferative diabetic retinopathy of any stage in the study eye
- •Written informed consent obtained from the subject prior to screening procedures
排除标准
- •Concurrent disease in the study eye, other than CI-DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- •Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
- •Any active ocular / intraocular infection or inflammation in either eye
- •Aphakic study eye
- •Poorly controlled Diabetes Mellitus
- •Uncontrolled hypertension
- •Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
研究组 & 干预措施
Ranibizumab + THR-317
Experimental
Subjects will receive intravitreal ranibizumab in combination with THR-317
干预措施: Ranibizumab 0.5mg (Drug)
Ranibizumab + THR-317
Experimental
Subjects will receive intravitreal ranibizumab in combination with THR-317
干预措施: THR-317 8mg (Drug)
Sham + ranibizumab
Active Comparator
Subjects will receive a sham injection in combination with intravitreal ranibizumab
干预措施: Ranibizumab 0.5mg (Drug)
Sham + ranibizumab
Active Comparator
Subjects will receive a sham injection in combination with intravitreal ranibizumab
干预措施: Sham injection (Drug)
结局指标
主要结局
Change from baseline in BCVA
时间窗: At Day 84 (Month 3)
次要结局
- Change from baseline in BCVA, by study visit(From Day 0 to Day 140)
- Change from baseline in CST, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre, by study visit(From Screening to Day 140)
- Withdrawal from repeat study treatment and reason for withdrawal(At Day 28 and at Day 56)
- Incidence of systemic and ocular adverse events including serious adverse events(From Day 0 to Day 140)
研究者
研究点 (37)
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