A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorGlostrup University Hospital, Copenhagen
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oral semaglutide
DrugParticipants 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
DrugParticipants 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)
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Oral SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Photopic 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.Secondary outcomes
1
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 3.2
Pelli-Robson chart contrast sensitivity test
Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
Time frame
From baseline to month 6.3
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 6.4
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.Other outcomes
1
Optical coherence tomography (OCT), ring scan
Structural glaucoma progression assessed by the OCT ring scan, which measures the retinal nerve fibre layer thickness.
Time frame
From baseline to month 6.2
Optical coherence tomography (OCT), macular scan
Structural glaucoma progression assessed by the OCT macular scan which measures the volume of retinal ganglion cells.
Time frame
From baseline to month 6.3
Standard automated perimetry
Visual field loss will be evaluated using standard automated perimetry. Progression will be measured by changes in mean deviation (MD).
Time frame
From baseline to month 6.4
Multi-omics
Changes in the cytokine proteome will be assessed by changes in concentrations of glaucoma-associated cytokines as related to inflammation. Changes in the metabolome and lipidome will be assessed by changes in plasma metabolomics and lipidomics.
Time frame
From baseline to month 6.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Glostrup University Hospital, Copenhagen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov