NCT07024693招募中2 期
A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- FECD Biomarkers: Splicing Panel
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.
- •≥30 years of age (inclusive).
- •Documented diagnosis of FECD in the study eligible eye.
- •Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.
- •Capable of giving signed informed consent.
排除标准
- •Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.
- •Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
- •Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
- •Concurrent or anticipated use of topical corticosteroids in the study eye.
- •Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
- •Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
- •Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.
- •Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.
- •Female participant is pregnant, planning a pregnancy, or breast-feeding.
- •Participant is unwilling to comply with the contraceptive requirements, as per protocol.
研究组 & 干预措施
Active
Experimental
Drug: DT-168
干预措施: DT-168 (Drug)
结局指标
主要结局
FECD Biomarkers: Splicing Panel
时间窗: Perioperative
Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.
次要结局
- Safety and Tolerability(Through study completion, an average of 4 weeks.)
研究者
研究点 (1)
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