NCT04187443招募中1 期
A Multicenter, Open-label, Dose Escalation Study Assessing the Safety and Treatment Effects of MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年6月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Treatment-emergent adverse events
研究概览
简要总结
This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria
- •Subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits;
- •All males and females must consent to pregnancy prevention during the study and qualified measures of birth control. All females of childbearing potential must consent to a pregnancy test before entering the study.
- •Presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherence tomography (sd-OCT) of the central retina subfield thickness (CRT) at the Screening Visit (Centration must be confirmed by Investigators with signatures);
- •Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visual acuity (VA);
- •Confirmation by the investigator that laser photocoagulation and anti-VEGF treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the Screening Visit;
- •Ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at Screening Visit.
排除标准
- •Subjects with unstable metabolic or blood pressure control
- •Subject with emaciation or obesity at Screening Visit: body mass index (BMI) <18.5kg/m2 or >28kg/m2
- •Current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol -
- •History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;
- •Any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at Screening Visit;
研究组 & 干预措施
MS-553 low dose
Experimental
low dose of MS-553 taken orally
干预措施: MS-553 (Drug)
MS-553 mid dose
Experimental
mid dose of MS-553 taken orally
干预措施: MS-553 (Drug)
MS-553 high dose
Experimental
high dose of MS-553 taken orally
干预措施: MS-553 (Drug)
结局指标
主要结局
Treatment-emergent adverse events
时间窗: Baseline to Day 56
次要结局
- Average mean change in best corrected visual acuity(Baseline to Day 56)
- Proportion of patients with resolution of central involved macular edema(Baseline to Day 56)
- Mean change in the retinal volume(Baseline to Day 56)
- Mean change in the central retina subfield thickness (CRT)(Baseline to Day 56)
- Proportion of patients with >20% reduction in CRT(Baseline to Day 56)
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis PigmentosaRetinitis PigmentosaRetinitis Pigmentosa SyndromeNCT05392751Endogena Therapeutics, Inc14
已完成
1 期
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast CancerHER2-negative Metastatic Breast CancerNCT05261269Dantari, Inc.30
招募中
1 期
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT06046495Avistone Biotechnology Co., Ltd.81
已完成
1 期
A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid TumorsNeoplasmsNCT02004106Hoffmann-La Roche110
已完成
1 期
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid TumorsAdvanced Solid TumorsUndifferentiated Pleomorphic SarcomaSquamous Cell Carcinoma of the Head and NeckCarcinoma of the BreastNCT02565758AbbVie85