Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06792422

Recruiting nowPhase 4Interventional

What this study 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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionPrimary Open Angle Glaucoma (POAG), Open-Angle Glaucoma, Glaucoma

Full registry criteria

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

Treatments and study arms

Oral semaglutide

Drug

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)

Placebo

Drug

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)

Primary outcomes

Photopic negative response of the electroretinogram after 6 monthsFrom baseline to month 6.

Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Ophthalmology, Rigshospitalet🇩🇰 Glostrup Municipality, Denmark
Miriam Kolko, MD, PhD, Professor, ConsultantContact