2024-520384-14-00
尚未招募
2 期
A randomised, double-masked, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of oral BI 1815368 in participants with centre-involved diabetic macular edema for 48 weeks of treatment (THULITE)
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 193
- 试验地点
- 35
- 主要终点
- Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48
概览
简要总结
Evaluate the dose-response relationship for BI 1815368 in participants with varying levels of vision impairment due to CI-DME
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosis of diabetes mellitus (DM) (type 1 or type 2), HbA1c <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
- •CI-DME confirmed on SD-OCT with CST ≥320 µm for male and ≥305 µm for female participants in the study eye at screening
- •BCVA visual acuity ETDRS letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening
- •Further inclusion criteria apply
排除标准
- •Macular edema considered to be due to other causes than CI-DME in the study eye
- •Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- •Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than Vabysmo® or Eylea® HD), and within 6 months before Day 1 for Vabysmo® or Eylea® HD, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
- •Any history of panretinal photocoagulation treatment, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of Iluvien® or Ozurdex® implants before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
- •Active ocular inflammation of any history of intraocular inflammation within 1 year
- •Aphakia or total absence of the posterior capsule; YAG laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1
- •Further exclusion criteria apply
结局指标
主要结局
Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48
Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48
次要结局
- Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
- Occurrence (yes/no) of drug-related AEs over the treatment period through EoS
- Absolute change from baseline of CST as measured by SD-OCT in the study eye at Week 48
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (35)
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