Actively Recruiting
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Led by Glostrup University Hospital, Copenhagen · Updated on 2025-01-24
126
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether oral semaglutide can improve inner retinal function in people with open-angle glaucoma, a common eye condition. The study aims to find out if semaglutide safely enhances the photopic negative response measured by an electroretinogram. Participants will be compared between those taking semaglutide and those taking a placebo, a look-alike pill without the drug. Participants will take oral semaglutide or a placebo daily for six months. The semaglutide dosing starts at 3 mg/day for the first month, increases to 7 mg/day for the second month, then continues at 14 mg/day for the remaining four months. The placebo group will take matching pills on the same schedule. The study involves five clinic visits: at the start, and after 1, 2, 3, and 6 months. During these visits, participants will undergo tests including the electroretinogram, contrast sensitivity tests, and assessments of health-related quality of life. Researchers will also monitor treatment-related adverse events over the six months. The main outcome is the change in the electroretinogram response after six months compared to baseline. The total participation time lasts six months with regular monitoring.
CONDITIONS
Brief 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 specific visual field loss (MD 64 16 dB) confirmed by standard automated perimetry
- Currently receiving intraocular pressure-lowering treatment for glaucoma
- Nerve fiber layer defects identified by optical coherence tomography (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
- Eye surgery within three months before inclusion
- Current smoker
- Pregnant or breastfeeding
- Females of childbearing potential not using adequate contraception
- Allergy to any drug ingredients used in the trial
- Untreated severe systemic disease or malignancies
- Previous history of pancreatitis
- Body mass index below 18.5
- Current treatment with certain diabetes or immune-related medications including Dipeptidyl peptidase-4 inhibitors, other GLP-1 receptor agonists, insulin, sulfonylurea, systemic corticosteroids, or immunosuppressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral semaglutide or placebo once daily with doses increasing over the first two months, followed by a maintenance dose for up to 6 months.
3 visits during the first 3 months and 1 visit at month 6
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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