2024-518510-87-00招募中4 期
Additive Benefits of Semaglutide for open-AngLe glaucoma – an Opportunity for Neuroprotection (ABSALON)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6.
研究概览
简要总结
The aim of this clinical trial is to investigate whether oral semaglutide can safely improve inner retinal function in patients with glaucoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 primary open-angle glaucoma with mean deviation (MD) ≤ 16 dB with repeatable and reliable (false positive less than 15 %) visual field loss measured by standard automated perimetry on at least one eye
- •Receiving intraocular pressure (IOP) lowering glaucoma treatment
- •Nerve fiber layer defects identified by optical coherence tomography (OCT)
排除标准
- •Diabetes or renal impairment
- •Previous history of pancreatitis
- •Subjects receiving treatment with: Dipeptidyl peptidase–4 inhibitors, Other GLP-1RAs, Insulin, Insulin analogues, Sulfonylurea, Systemic corticosteroids, or Immunosuppressants
- •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
- •Subjects allergic to drug ingredients administered during the trial
- •Subjects with untreated severe systemic disease or malignancies
结局指标
主要结局
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6.
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6.
次要结局
- Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 3.
- Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
- Health-related quality of life (HRQoL) assessed using two standardized validated questionnaires administered in Danish; the European Quality of life – 5 Dimensions – 3 Levels (EQ-5D-3L) questionnaire and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
- Safety and tolerance of oral semaglutide treatment in patients with glaucoma assessed by incidence of treatment emergent adverse events (TEAEs) and changes in safety-related blood analysis.
研究者
Miriam Kolko
Scientific
Rigshospitalet
研究点 (1)
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