RecruitingPhase 4NCT06792422

A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma

Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection

Sponsor

Glostrup University Hospital, Copenhagen

Enrollment

126 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Open Angle Glaucoma Glaucoma Primary Open Angle Glaucoma (POAG)

Summary

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).

Eligibility

Min Age: 45 Years

Inclusion Criteria6

Ability to read and speak Danish
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 Criteria12

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

Interventions

DRUGOral semaglutide

Participants will receive oral semaglutide once daily. 1. Starting dose 3 mg/day for one month (day 1-28) 2. Intermediate dose 7 mg/day for one month (day 29-56) 3. Maintenance dose 14 mg/day (day 57-182)

DRUGPlacebo

Participants will receive an oral placebo once daily. 1. Placebo tablets received on visit 1 (baseline) for one month (day 1-28) 2. Placebo tablets received on visit 2 (month 1) for one month (day 29-56) 3. Placebo tablets received on visit 3 (month 2) for four months (day 57-182)