Study on the Effects of Semaglutide for Patients with Glaucoma

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What is this study about?

This clinical trial is focused on studying the effects of a medication called semaglutide on a condition known as glaucoma. Glaucoma is an eye disease that can lead to vision loss by damaging the optic nerve, which is crucial for good eyesight. The medication being tested is taken orally in the form of tablets, known as Rybelsus, and comes in different strengths: 3 mg, 7 mg, and 14 mg. The purpose of the study is to see if semaglutide can safely improve the function of the inner part of the retina, which is the light-sensitive layer at the back of the eye, in people with glaucoma.

Participants in the study will receive either the semaglutide tablets or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for several months, during which participants will take the tablets and have regular check-ups to monitor their eye health and overall well-being. The study aims to assess changes in the retina’s function and the progression of glaucoma, as well as the safety and tolerance of semaglutide in patients with this condition.

Throughout the study, participants’ quality of life will also be evaluated using questionnaires. These assessments will help determine if semaglutide can offer additional benefits for people with glaucoma, potentially providing a new approach to protecting the eyes from further damage. The trial is expected to continue until 2028, with recruitment starting in 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, language proficiency, and glaucoma diagnosis.

Participants must be 45 years or older, able to read and speak Danish, and have a visual acuity of at least 0.5 in the study eye.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes evaluating the inner retinal function using an electroretinogram and assessing visual field loss.

Participants must have a diagnosis of primary open-angle glaucoma with specific visual field loss criteria.

3 medication administration

Participants receive oral semaglutide tablets. The tablets are administered in varying dosages: 3 mg, 7 mg, and 14 mg.

The medication is taken orally, and the specific dosage and frequency are determined by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments are conducted to monitor changes in retinal function and overall health.

These assessments include electroretinogram tests at baseline, month 3, and month 6, as well as contrast sensitivity tests and quality of life questionnaires.

5 safety monitoring

Safety and tolerance of the medication are closely monitored. This involves tracking any adverse events and conducting regular blood tests.

Participants are observed for any treatment-emergent adverse events to ensure the medication’s safety.

6 completion of the study

The study is expected to conclude by August 31, 2028. Final assessments are conducted to evaluate the overall impact of the treatment on retinal function and quality of life.

Participants’ data is analyzed to determine the effectiveness and safety of oral semaglutide in treating glaucoma.

Who Can Join the Study?

Must be able to read and speak Danish.
Must be 45 years or older at the time of joining the study.
Must have a visual acuity of 0.5 or better in the eye being studied. Visual acuity is a measure of how well you can see details at a distance.
Must have a diagnosis of primary open-angle glaucoma. This is a common type of glaucoma where the eye’s drainage canals become clogged over time, leading to increased eye pressure.
Must have a mean deviation (MD) of 16 decibels (dB) or less. This is a measure used in visual field tests to assess the extent of vision loss.
Must have repeatable and reliable visual field loss, with less than 15% false positives. Visual field tests check for gaps in your vision.
Must be receiving treatment to lower intraocular pressure (IOP). This is the pressure inside the eye, which is often higher in people with glaucoma.
Must have nerve fiber layer defects identified by optical coherence tomography (OCT). OCT is a scan that provides detailed images of the eye’s structures.

Who Cannot Join the Study?

Patients who are not diagnosed with glaucoma cannot participate. Glaucoma is a condition that affects the eyes and can lead to vision loss.
Individuals who are younger than 18 years old or older than 65 years old are not eligible.
Participants must not be part of any vulnerable population, which means they should not be in a group that needs special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	14.10.2024

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication being studied in this clinical trial to see if it can help improve the function of the inner retina in patients with glaucoma. It is taken orally and is being evaluated for its potential neuroprotective benefits in this condition.

Investigated diseases:

Glaucoma

Glaucoma – Glaucoma is a group of eye conditions that damage the optic nerve, which is vital for good vision. This damage is often caused by an abnormally high pressure in the eye. Over time, increased pressure can erode the optic nerve tissue, which may lead to vision loss or even blindness if not managed. The progression of glaucoma is typically gradual, and it may not be noticed until significant vision loss has occurred. It can affect one or both eyes and is more common in older adults. Regular eye exams are crucial for early detection and management of this condition.

Trial ID:

2024-518510-87-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Semaglutide for Patients with Glaucoma

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