NCT06792422招募中4 期
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Glostrup University Hospital, Copenhagen1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Photopic negative response of the electroretinogram after 6 months
研究概览
简要总结
The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. The main question it aims to answer is: Does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram.
Researchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug).
Participants will:
- Take semaglutide or a placebo every day for 6 months.
- Visit the clinic 5 times in total for tests and interviews: At baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to read and speak Danish
- •45 years or older at the time of inclusion
- •Visual acuity equal to or above 0.5 in the study eye
- •Diagnosis of POAG with MD ≤ 16 dB with repeatable and reliable (false positive less than 15 %) VF loss measured by standard automated perimetry on at least one eye
- •Receiving IOP-lowering glaucoma treatment
- •Nerve fiber layer defects identified by OCT
排除标准
- •Diabetes or renal impairment
- •Medical history of significant eye disease (including ocular trauma) other than glaucoma
- •Ocular inflammation/infection within three months from inclusion
- •Intraocular surgery 3 months before inclusion
- •Smoker at the time of inclusion
- •Pregnant or breast-feeding
- •Females of childbearing potential who are not using adequate contraceptive, which includes the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner; Sexual abstinence
- •Subjects allergic to drug ingredients administered during the trial
- •Subjects with untreated severe systemic disease or malignancies
- •Previous history of pancreatitis
- •BMI < 18.5
- •Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants
研究组 & 干预措施
Oral Semaglutide
Experimental
Participants are given oral semaglutide once daily.
干预措施: Oral semaglutide (Drug)
Placebo
Placebo Comparator
Participants are given oral placebo once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Photopic negative response of the electroretinogram after 6 months
时间窗: From baseline to month 6.
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.
次要结局
- Photopic negative response of the electroretinogram after 3 months(From baseline to month 3.)
- Pelli-Robson chart contrast sensitivity test(From baseline to month 6.)
- Health-related quality of life (HRQoL)(From baseline to month 6.)
- Number of treatment-related adverse events as assessed by CTCAE v5.0(From baseline to month 6.)
研究者
Miriam Kolko
Professor in Translational Eye Research, Chief Physician.
Rigshospitalet, Denmark
研究点 (1)
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