A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Recruiting · NCT06792422 · Interventional (participants receive a specific treatment) · Lead sponsor: Glostrup University Hospital, Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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 criteria
- Diabetes or renal impairment
- 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, 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
- Subjects allergic to drug ingredients administered during the trial
- Subjects with untreated severe systemic disease or malignancies
- Previous history of pancreatitis
- BMI \< 18.5
- Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants
Where it is running
1 location listed.
- Department of Ophthalmology, Rigshospitalet - Glostrup Municipality, Denmark