NCT07228559终止1 期
A Phase 1b Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat In Participants With Diabetic Macular Edema
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 13
- 主要终点
- The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).
研究概览
简要总结
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
详细描述
Study BCX4161-111 is an open-label, single ascending dose study with 24 weeks follow-up in participants with DME. Three cohorts with a minimum of 3 participants enrolled in each cohort with 3 dose levels of avoralstat (low, medium, high) are planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Glycated hemoglobin A (HbA1c) < 10% at screening
- •Diagnosis of DME with center involvement requiring medical treatment within 6 months of screening and decreased visual acuity attributable to DME
- •Mild-to-severe non-proliferative diabetic retinopathy (NPDR) with DRSS < 61 in the study eye at screening
- •BCVA between 35 and 80 ETDRS letters (20/25 to 20/200 Snellen equivalent), inclusive, in the study eye at screening
- •CST measured by Heidelberg OCT between 325 and 600 μm in the study eye at screening
排除标准
- •Participants who have previously received more than 3 anti-VEGF injections
- •Any history of retinal surgery or other surgical intervention for diabetic ocular complications or anticipated need for use of laser photocoagulation course of any of the procedures listed in the criteria in the study eye during the study period
- •Current medically untreated diabetes mellitus or previous medically untreated diabetes mellitus with initiation of oral or injectable anti-diabetic medication ≤ 3 months prior to screening
- •Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •Intraocular surgery ≤ 3 months prior to screening or anticipated need for ocular surgery in the study eye during the study period
研究组 & 干预措施
Single dose suprachoroidal injection of avoralstat
Experimental
干预措施: avoralstat (Drug)
结局指标
主要结局
The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).
时间窗: From screening through EOS (Week 24)
次要结局
- Therapeutic potential of avoralstat in participants with DME. Trends in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT).(From baseline through Weeks 12 and 24)
- Therapeutic potential of avoralstat in participants with DME. Trends in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA).(From baseline through Weeks 12 and 24)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
A Study to Assess Safety and Tolerability of GS1-144 in Healthy VolunteersVasomotor SymptomsAdult Healthy VolunteersNCT06204250Changchun GeneScience Pharmaceutical Co., Ltd.86
已完成
1 期
An Absolute Bioavailability Study in Healthy Participants Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)Healthy VolunteersNCT01249118Genentech, Inc.13
招募中
1 期
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.AnemiaNCT05773586Ascentage Pharma Group Inc.105
已完成
1 期
Evaluation of LBL-003 Phase I Study in Patients With Advanced MalignanciesAdvanced Malignant TumorNCT05042908Nanjing Leads Biolabs Co.,Ltd18
撤回
1 期
Phase 1 Single Subcutaneous Dose Study of MLN1202Healthy Japanese and Caucasian Male AdultsNCT02426021Takeda