A Phase 4 interventional study of Oral semaglutide and Placebo in Primary Open Angle Glaucoma (POAG), Open-Angle Glaucoma and Glaucoma, sponsored by Glostrup University Hospital, Copenhagen. Recruiting at 1 site in Denmark. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Glostrup University Hospital, Copenhagen · Phase 4, Interventional, and Treatment
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:
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 126 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Glostrup University Hospital, Copenhagen is the lead sponsor of 106 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are given oral semaglutide once daily.
Drug: Oral semaglutide
Participants are given oral placebo once daily.
Drug: Placebo
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)
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.
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.
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.
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.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Aug 2028, 43 months later.
Of 45 phase 4 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 43 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Semaglutide
Glostrup University Hospital, Copenhagen →