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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
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)
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)
Department of Ophthalmology, Rigshospitalet
Glostrup Municipality, Denmark
RECRUITINGPhotopic negative response of the electroretinogram after 6 months
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.
Time frame: From baseline to month 6.
Photopic negative response of the electroretinogram after 3 months
Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram.
Time frame: From baseline to month 3.
Pelli-Robson chart contrast sensitivity test
Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
Time frame: From baseline to month 6.
Health-related quality of life (HRQoL)
Health-related quality of life (HRQoL) assessed with the European Quality of life - 5 Dimensions - 3 Levels (EQ-5D-3L) questionnaire, a standardized validated questionnaire administered in Danish. The EQ-5D-3L questionnaire comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame: From baseline to month 6.
Health-related quality of life (HRQoL)
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.
Time frame: From baseline to month 6.
Number of treatment-related adverse events as assessed by CTCAE v5.0
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.
Time frame: From baseline to month 6.
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