Oral semaglutide tested in people with open-angle glaucoma
Tests whether daily oral semaglutide, compared with a placebo, may help people with open-angle glaucoma.
Plain-language title generated from the registry record
Registry title: A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Key facts
- Where
- Glostrup, DenmarkSee the site
- Phase
- Phase 4
Where in Denmark
- RigshospitaletGlostrup, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Glostrup University Hospital, Copenhagen
- Trial code
- NCT06792422EU 2024-518510-87-00
- Record updated
- 24 January 2025
- Original description
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.Read full original descriptionShow less
Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
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).
Inclusion: 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.
Exclusion: Intraocular surgery 3 months before inclusion; Previous history of pancreatitis; Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants; Diabetes or renal impairment; Medical history of significant eye disease (including ocular trauma) other than glaucoma; Ocular inflammation/infection within three months from inclusion; Subjects allergic to drug ingredients administered during the trial; Subjects with untreated severe systemic disease or malignancies; 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; BMI < 18.5.