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

Phase 4

Recruiting

• Conditions: Primary Open Angle Glaucoma (POAG); Open-Angle Glaucoma; Glaucoma
• Interventions: Drug: Oral semaglutide; Drug: Placebo

• Registration Number: NCT06792422
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-18
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2028-08
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Semaglutide	Oral semaglutide	Participants are given oral semaglutide once daily.
Placebo	Placebo	Participants are given oral placebo once daily.

Primary Outcome Measures

Name	Time	Method
Photopic negative response of the electroretinogram after 6 months	From baseline to month 6.	Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.

Secondary Outcome Measures

Name	Time	Method
Photopic negative response of the electroretinogram after 3 months	From baseline to month 3.	Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.
Pelli-Robson chart contrast sensitivity test	From baseline to month 6.	Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
Health-related quality of life (HRQoL)	From baseline to month 6.	Health-related quality of life (HRQoL) assessed with the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25), a standardized validated questionnaire administered in Danish. The scoring system for the NEI VFQ-25 generates 12 subscale scores and an overall composite score. A higher score indicates a higher level of functioning.
Number of treatment-related adverse events as assessed by CTCAE v5.0	From baseline to month 6.	Safety and tolerance of oral semaglutide treatment in patients with glaucoma assessed by the incidence of treatment-emergent adverse events (TEAEs) by CTCAE v5.0.

Trial Locations

Locations (1)

Department of Ophthalmology, Rigshospitalet; 🇩🇰 Glostrup, Denmark