Actively Recruiting
Study of Oral Semaglutide for Neuroprotection in Open-Angle Glaucoma Assessing Retinal Function Improvements Over Six Months
Led by Glostrup University Hospital, Copenhagen · Updated on 2025-01-24
126
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine if oral semaglutide can safely improve inner retinal function in adults with open-angle glaucoma. The study focuses on measuring changes in the photopic negative response of the electroretinogram over six months to evaluate treatment effects. Participants will be adults aged 45 or older who have primary open-angle glaucoma and are already receiving treatment to lower eye pressure. Participants will be randomly assigned to receive either oral semaglutide or a placebo daily for six months. The semaglutide dosing starts with 3 mg per day for the first month, increases to 7 mg per day for the second month, and then continues with 14 mg per day for the remaining four months. The placebo group will receive matching tablets on a similar schedule. The study includes five clinic visits: at baseline, and after 1, 2, 3, and 6 months. During these visits, participants will undergo tests and interviews to monitor their eye function and safety. Researchers will evaluate the main outcome by comparing the photopic negative response of the electroretinogram from the start to six months. The study will also monitor participants for any side effects and overall health throughout the trial period.
CONDITIONS
Official Title
A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 of 16 dB or less and reliable visual field loss in at least one eye
- Currently receiving intraocular pressure-lowering glaucoma treatment
- Nerve fiber layer defects identified by OCT
You will not qualify if you...
- Diabetes or renal impairment
- Significant eye disease other than glaucoma, including ocular trauma
- Eye inflammation or infection within three months before inclusion
- Intraocular surgery within three months before inclusion
- Current smoker
- Pregnant or breastfeeding
- Females of childbearing potential not using adequate contraception
- Allergy to drug ingredients used in the trial
- Untreated severe systemic diseases or malignancies
- Previous history of pancreatitis
- Body mass index below 18.5
- Current treatment with Dipeptidyl peptidase-4 inhibitors, other GLP-1 receptor agonists, insulin or insulin analogues, sulfonylurea, systemic corticosteroids, or immunosuppressants
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
M
Miriam Kolko, MD, PhD
A
Anna-Sophie Thein
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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