What is oral semaglutide studying for open-angle glaucoma?

Oral semaglutide is being studied to see if it can safely improve inner retinal function in people with open-angle glaucoma. Researchers want to know if this treatment affects the eye's electrical response measured by an electroretinogram. The trial is sponsored by Glostrup University Hospital in Copenhagen and compares semaglutide to a placebo.

Who may be eligible for this open-angle glaucoma clinical trial?

Adults aged 45 years or older with a diagnosis of primary open-angle glaucoma and receiving eye pressure-lowering treatment may be eligible. Participants must also be able to read and speak Danish and meet specific eye health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this open-angle glaucoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect regular clinic visits for tests and monitoring over six months.

Actively Recruiting

Phase 4

Age: 45Years +

All Genders

ID06792422

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

Research Sites

17 weeks

Total Duration

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 mgday for the first month, increases to 7 mgday for the second month, then continues at 14 mgday 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

Age: 45Years +

All Genders

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

Research Team

Miriam Kolko, MD, PhD

Anna-Sophie Thein

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