Clinical trial NCT06792422: A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Official title: Additive Benefits of Semaglutide for Open-AngLe Glaucoma - an Opportunity for Neuroprotection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Open Angle Glaucoma (POAG)
Open-Angle Glaucoma
Glaucoma
Keywords: Glaucoma
Semaglutide
Rybelsus
Primary Open Angle Glaucoma
GLP-1RA
Photopic Negative Response
GLP-1
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 126
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Photopic negative response of the electroretinogram after 6 months
timeFrame: From baseline to month 6.
Secondary outcomes:
measure: Photopic negative response of the electroretinogram after 3 months
timeFrame: From baseline to month 3.
measure: Pelli-Robson chart contrast sensitivity test
timeFrame: From baseline to month 6.
measure: Health-related quality of life (HRQoL)
timeFrame: From baseline to month 6.
measure: Health-related quality of life (HRQoL)
timeFrame: From baseline to month 6.
measure: Number of treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: From baseline to month 6.
Other outcomes:
measure: Optical coherence tomography (OCT), ring scan
timeFrame: From baseline to month 6.
measure: Optical coherence tomography (OCT), macular scan
timeFrame: From baseline to month 6.
measure: Standard automated perimetry
timeFrame: From baseline to month 6.
measure: Multi-omics
timeFrame: From baseline to month 6.
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet
Study officials:
References: