CTRI/2019/06/019817进行中（未招募）3 期
ong-term effects of semaglutide on diabeticretinopathy in subjects with type 2 diabetes (FOCUS)
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Informed consent obtained before any trial-related activities. Trial-related activities are any
- •procedures that are carried out as part of the trial, including activities to determine suitability for
- •2. Male or female, age =18 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus = 10 years prior to the day of screening.
- •4. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
- •Eye inclusion criteria (both eyes must meet all criteria):
- •5. ETDRS level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by
- •central reading centre.
- •6. No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema twelve
- •months prior to the day of screening.
- •7. No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic
- •macular oedema within six months after randomisation.
- •8. Best-corrected visual acuity =30 letters using the ETDRS visual acuity protocol.
- •9. No previous treatment with pan-retinal laser photocoagulation
- •10. 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.
- •11. No substantial media opacities that would preclude successful imaging.
排除标准
- •Subjects are excluded from the trial if any of the following criteria apply:
- •1. 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.
- •2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •3. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •4. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of
- •eGFR less than 30 ml per min per 1.73 m2.
- •5. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •6. 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.
- •7. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
- •8. Current or previous (within 30 days before screening) treatment with any GLP-1 receptor agonist or DPP-4 inhibitor.
- •9. Receipt of any investigational medicinal product within 30 days before screening.
- •10. Previous participation in this trial. Participation is defined as randomisation.
- •11. Known or suspected hypersensitivity to trial products or related products.
- •12. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or
- •compliance with the protocol.
- •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.
研究者
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