EUCTR2017-003619-20-SK进行中（未招募）1 期
ong-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes - FOCUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female, age equal to or above 18 years at the time of signing informed consent.
- •- Diagnosed with type 2 diabetes mellitus.
- •- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
- •Eye inclusion criteria (both eyes must meet the following criteria):
- •- ETDRS level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre.
- •- No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
- •- No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
- •- Best-corrected visual acuity equal to or above 30 letters using the ETDRS visual acuity protocol.
- •- No previous treatment with pan-retinal laser photocoagulation.
- •- No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial.
- •- No substantial media opacities that would preclude successful imaging.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening.
- •- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR below 30 ml/min/1.73 m^2 (Based on medical history using latest available and no more than 6 months old assessment. If not available in medical records a local laboratory measurement must be made available before randomisation).
- •- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
- •- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- •- Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
- •- Receipt of any investigational medicinal product within 30 days before screening.
- •- Previous participation in this trial. Participation is defined as randomisation.
- •- Known or suspected hypersensitivity to trial products or related products.
- •- Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
研究者
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